This document summarizes Astron Research Ltd, a featured developer in the Global Generic Product Directory. Astron is an Indian pharmaceutical company established in 2001 that develops and manufactures generic pharmaceutical products. It has dossiers for over 100 molecules ready or in development for global markets. Astron has capabilities across the pharmaceutical value chain including API manufacturing, finished dose production, marketing and distribution. It is seeking partnerships for product development and commercialization.
Biotech Resources Group's GMP Consulting service works with client companies globally to design, build, start-up, operate, and optimize licensable cGMP facilities for biologics projects. They work with clients throughout the concept-to-commercialization process at both clinical and commercial scales. In 2013, the biotechnology economy remained strong, fueling growth for innovator, biosimilar, and CMO companies. Biotech Resources' main goal is to help clients improve their competitive position by advancing needed medicines through development and to market. They believe in strongly integrating with client teams to bring new medicines to patients.
Oliver Vit is a Swiss citizen with over 20 years of experience in the pharmaceutical industry. He holds a Bachelor's degree in Chemistry from New York University and postgraduate degrees from the University of London and University of Oxford. Vit currently works as a Senior Life Cycle Project Manager at Actelion Pharmaceuticals Ltd in Basel, Switzerland, where he has led multi-disciplinary teams and managed drug development programs from early research through regulatory approval and launch. He is fluent in English, French, and German with conversational Spanish.
This document discusses Actelion Pharmaceuticals' desire to partner its S1P1 agonist program. It provides background on Actelion and the program. It then discusses trends in pharmaceutical partnering over the last 30 years, with alliances rising to displace other forms of partnerships. The document goes on to describe a stage-gate approach to identify potential partner candidates. It applies scoring tools and risk analysis to 6 firms to identify the most appropriate partners for due diligence.
Generic Pharma 2.0 Masters of Business Development & MarketingGeneric Pharma 2.0
Introduction to Generic Pharma 2.0
- Business Development Toolkit
- Portfolio Consulting
- Digital Marketing
- Lead Generation & Conversion
- Design & Creative
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
Biotech Resources Group's GMP Consulting service works with client companies globally to design, build, start-up, operate, and optimize licensable cGMP facilities for biologics projects. They work with clients throughout the concept-to-commercialization process at both clinical and commercial scales. In 2013, the biotechnology economy remained strong, fueling growth for innovator, biosimilar, and CMO companies. Biotech Resources' main goal is to help clients improve their competitive position by advancing needed medicines through development and to market. They believe in strongly integrating with client teams to bring new medicines to patients.
Oliver Vit is a Swiss citizen with over 20 years of experience in the pharmaceutical industry. He holds a Bachelor's degree in Chemistry from New York University and postgraduate degrees from the University of London and University of Oxford. Vit currently works as a Senior Life Cycle Project Manager at Actelion Pharmaceuticals Ltd in Basel, Switzerland, where he has led multi-disciplinary teams and managed drug development programs from early research through regulatory approval and launch. He is fluent in English, French, and German with conversational Spanish.
This document discusses Actelion Pharmaceuticals' desire to partner its S1P1 agonist program. It provides background on Actelion and the program. It then discusses trends in pharmaceutical partnering over the last 30 years, with alliances rising to displace other forms of partnerships. The document goes on to describe a stage-gate approach to identify potential partner candidates. It applies scoring tools and risk analysis to 6 firms to identify the most appropriate partners for due diligence.
Generic Pharma 2.0 Masters of Business Development & MarketingGeneric Pharma 2.0
Introduction to Generic Pharma 2.0
- Business Development Toolkit
- Portfolio Consulting
- Digital Marketing
- Lead Generation & Conversion
- Design & Creative
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
Beximco Pharmaceuticals Ltd. is a leading Bangladeshi pharmaceutical company established in 1976. It has over 2,500 employees and manufacturing facilities certified by global regulatory bodies. Beximco Pharma produces over 400 products across various therapeutic categories and is the largest exporter of pharmaceuticals in Bangladesh. The company has a growing global presence across five continents and is the only Bangladeshi pharmaceutical company marketing products in the US.
This document provides information about OTC and biosimilar products from various companies. It features the company Geiser Pharma which develops both generic and OTC products for out-licensing. The supplement also lists OTC product profiles from Geiser Pharma including stick packs, lozenges, laxatives and medical devices for conditions like cough, heartburn, sore throat, constipation and ear issues. Contact information is provided to obtain more details on product dossiers and technical services.
DM Technologies is a pharmaceutical consulting and engineering firm incorporated in 1994 that works with clients across 5 continents. It offers a range of specialized manufacturing services including soft gelatin capsule design, extrusion and spheronization equipment, vacuum mixing technologies, and more. DM Technologies partners with several equipment suppliers and engineering firms to provide its services and has a client list of major pharmaceutical companies. It aims to offer partners market exclusivity, technical support, and equipment after-sales support in exchange for proactive marketing efforts and loyalty from its partners.
This document summarizes Meda Biotech's Hybrid-Nanoengineering technology platform for developing nanomedicines. It offers a solution for solubility problems with novel drugs through patent-protected products developed within three weeks at no upfront charge. Meda is seeking strategic partners to further develop its 160 molecules for clinical trials and license its existing clinical pipeline products and pre-clinical drugs.
Efarmes is a Spanish pharmaceutical company that offers generic drug development and manufacturing services. It has laboratories and manufacturing facilities for developing and producing solid, liquid, and semi-solid generic drug products. Efarmes licenses existing generic drug dossiers, provides custom generic drug development and manufacturing, and partners with other companies on co-development projects. It supplies generic drugs to various pharmaceutical companies around the world.
Yaohai Bio-Pharma is the first and the largest biologics CRTDMO (Contract Research, Testing, Development and Manufacturing Organization) focusing on microbial expression system in China, which was established in China Medical City, Taizhou with a 20, 000 square meters plant.
As a one-stop biologics CRTDMO, Yaohai provide customized end-to-end solutions from DNA to drug substance manufacturing and product fill & finish across diversified modalities, such as recombinant proteins, peptides and polypeptides, enzymes, antibody fragments and nano-antibodies, plasmid DNA and mRNA, Glyco-polymers, virus-like particle (VLP), to meet global customers’ clinical and commercial needs in biological drugs, biosimilars, vaccines and diagnostics for human and veterinary use.
https://www.yaohai-bio.com.cn/downloadfile
The document discusses various aspects of new product development for cosmetics, household, and insecticide products. It begins with an overview of the product development process and importance of satisfying consumer wants. Several examples of new product development are provided, including the development of a toilet bowl blue block and wardrobe insect repellent. Key steps in the process like ideation, product specifications, testing, manufacturing, and launch are covered. Trends in new product development like outsourcing and centralization are also summarized.
Maxheal Pharmaceuticals is an Indian pharmaceutical company with a vision to become a global player by 2015. It has experienced rapid growth since starting as a small retail pharmacy in the 1980s. The company exports pharmaceutical products to over 15 countries in Africa, Asia, and Latin America. In 2008, Maxheal acquired Ally Pharma, adding manufacturing capacity and approvals to sell in more African countries. Maxheal plans further expansion through an IPO and developing new product lines.
Power point presentation march 21 revisionteleprodirect
TelePro-Direct seeks funding to market Z Clear, a new Benzoyl Peroxide-free acne treatment. Z Clear uses patented technology from Columbia University to treat acne without the side effects of Benzoyl Peroxide. The $3 billion acne market is currently dominated by Proactiv, which uses Benzoyl Peroxide and causes skin irritation. Z Clear has the potential to capture significant market share by offering an effective alternative. TelePro-Direct has assembled an experienced team and developed a marketing plan to launch Z Clear through direct response advertising. They are seeking $1.2 million to fund marketing, production, inventory, and other launch expenses.
Procter & Gamble was founded in 1837 by William Procter and James Gamble. It originally produced candles and soap but pivoted to soap production for the Union army during the Civil War. Today, P&G operates across 180 countries and is organized into two global business units: Health and Well-Being and Beauty. Its largest segments are Fabric and Home Care, Beauty, and Baby Care and Family Care. P&G aims to acquire 1 billion new consumers by 2015 through expansion in developing markets and increasing productivity across operations.
Zhermack specializes in the production of materials and equipment for dental practices and dental laboratories, and provides its customers products whose trademarks are constant innovation and excellent quality.
Zhermack, undisputed leader in impression material production, was founded in 1981 and quickly positioned itself among the most important companies in the dental sector.
Besides its headquarters in Italy, Zhermack has branches in Germany, the United States and Poland and has Representative Offices in key locations such as Russia, United Kingdom, Spain, France, Mexico, Colombia and Turkey.
The widespread distribution network, with over 800 distributors worldwide, guarantees global sales coverage.
This document outlines a business plan for producing therapeutic proteins like vaccines and alpha-1 antitrypsin using tobacco plants. It discusses using tobacco's manufacturing capabilities to rapidly and cost-effectively produce proteins. Target markets include seasonal flu vaccines, pandemic flu vaccines, and alpha-1 antitrypsin for treating deficiencies. The plan involves outsourcing manufacturing activities and establishing partnerships with larger biotech companies and government organizations. Financial metrics like costs, pricing, and capital requirements are considered to evaluate feasibility and profitability.
Bio-Agro (Pvt) Limited has over 30 years of experience in agricultural products in Sri Lanka. They own over 12,000 acres of farmland and distribute a variety of products nationwide. For this analysis, we focused on their fruit juice offerings. Bio-Agro has a strong distribution network and loyal customer base due to their quality products and services. However, as a private limited company they face limitations in capital and expansion. Opportunities exist in receiving government support for agricultural products and a stable economy. Threats include weather-dependent supply and increased competition in the market.
This is a basic report of BEXIMCO pharma industry. Only basic tools and topics of management were used to prepare this report. This report might help the students who are doing MGT 210 COURSE in North South University of BANGLADESH.
Global Pharmas is a life sciences advisory firm serving the pharmaceutical and biotech industries. They deliver solutions for organizational effectiveness, branding, business development, and market entry. Their team has extensive experience in commercial roles. Global Pharmas represents clients seeking licensing deals for late-stage or commercialized products with differentiation. They identify opportunities, approach owners, and facilitate deals in key therapeutic areas like pain, respiratory, and dermatology.
Guavas originally come from the tropical regions of America.
The vitamin wealth of the guava is extraordinary. It is rich in vitamin C. It also contains pectin, provitamin A, vitamin B, iron, potassium and calcium.
Due to their high vitamin content, guavas have a preventive effect against colds.
In addition, they help with hyperacidity,
promotes digestion,
inhibit inflammation and
stabilize the immune system.
This document discusses coding technologies used to combat counterfeit pharmaceuticals. It describes overt coding methods like size, shape, and logos but notes these can be copied. Covert coding uses chemical or physical markers added invisibly. Regulatory barriers have hindered adoption of coding technologies but guidelines from the FDA have helped. Cost is also an issue, especially for generic drug makers. Future solutions may use nanotechnology and mobile phone verification to authenticate drugs for patients and ensure the correct personalized formulation.
Pharmacelera develops software and hardware solutions to accelerate drug discovery by finding better candidate molecules faster and in less time. Their technology includes a database of fragments and compounds with pre-computed descriptors, molecular simulation software that models interaction fields, and a computing platform with hardware accelerators. Pharmacelera has achieved strong growth since 2015 through international expansion and new technology releases. They are presenting at the President's Startup Challenge to gain recognition, mentorship, and advisory support to further accelerate their strategy and internationalization.
The document discusses ChromaDex's business model, which involves a legacy standards and analytical services business that provides market intelligence used to identify and acquire early-stage ingredient technologies. These technologies are developed and commercialized in multi-billion dollar markets like dietary supplements, food and beverage, cosmeceuticals, and pharmaceuticals. An example case study is provided on ChromaDex's acquisition, development, and commercialization of pterostilbene under the brand name pTeroPure, including a clinical study showing it significantly lowers blood pressure.
General Project is an Italian company that has designed and produced high-quality medical and aesthetic equipment for over 15 years. It employs 35 people in Florence, Italy and has two plants and a showroom. General Project aims to develop innovative technological products for body care and beauty to improve well-being. Its product range includes equipment for facial care, intense pulsed light therapy, laser therapy, microdermabrasion, and body contouring using ultrasound.
New Pharma Magazine is holding its launch party in New York City on March 14th during DCAT Week. The magazine is the premier source for news, events, and lifestyle insights for decision makers in the pharmaceutical industry. Key industry leaders such as Ed Borkowski and Stu Williams will attend the exclusive cocktail event at the W Hotel New York along with the president of Generic Pharma 2.0. New Pharma Magazine focuses on engaging readers on strategic issues facing the changing pharmaceutical industry.
Beximco Pharmaceuticals Ltd. is a leading Bangladeshi pharmaceutical company established in 1976. It has over 2,500 employees and manufacturing facilities certified by global regulatory bodies. Beximco Pharma produces over 400 products across various therapeutic categories and is the largest exporter of pharmaceuticals in Bangladesh. The company has a growing global presence across five continents and is the only Bangladeshi pharmaceutical company marketing products in the US.
This document provides information about OTC and biosimilar products from various companies. It features the company Geiser Pharma which develops both generic and OTC products for out-licensing. The supplement also lists OTC product profiles from Geiser Pharma including stick packs, lozenges, laxatives and medical devices for conditions like cough, heartburn, sore throat, constipation and ear issues. Contact information is provided to obtain more details on product dossiers and technical services.
DM Technologies is a pharmaceutical consulting and engineering firm incorporated in 1994 that works with clients across 5 continents. It offers a range of specialized manufacturing services including soft gelatin capsule design, extrusion and spheronization equipment, vacuum mixing technologies, and more. DM Technologies partners with several equipment suppliers and engineering firms to provide its services and has a client list of major pharmaceutical companies. It aims to offer partners market exclusivity, technical support, and equipment after-sales support in exchange for proactive marketing efforts and loyalty from its partners.
This document summarizes Meda Biotech's Hybrid-Nanoengineering technology platform for developing nanomedicines. It offers a solution for solubility problems with novel drugs through patent-protected products developed within three weeks at no upfront charge. Meda is seeking strategic partners to further develop its 160 molecules for clinical trials and license its existing clinical pipeline products and pre-clinical drugs.
Efarmes is a Spanish pharmaceutical company that offers generic drug development and manufacturing services. It has laboratories and manufacturing facilities for developing and producing solid, liquid, and semi-solid generic drug products. Efarmes licenses existing generic drug dossiers, provides custom generic drug development and manufacturing, and partners with other companies on co-development projects. It supplies generic drugs to various pharmaceutical companies around the world.
Yaohai Bio-Pharma is the first and the largest biologics CRTDMO (Contract Research, Testing, Development and Manufacturing Organization) focusing on microbial expression system in China, which was established in China Medical City, Taizhou with a 20, 000 square meters plant.
As a one-stop biologics CRTDMO, Yaohai provide customized end-to-end solutions from DNA to drug substance manufacturing and product fill & finish across diversified modalities, such as recombinant proteins, peptides and polypeptides, enzymes, antibody fragments and nano-antibodies, plasmid DNA and mRNA, Glyco-polymers, virus-like particle (VLP), to meet global customers’ clinical and commercial needs in biological drugs, biosimilars, vaccines and diagnostics for human and veterinary use.
https://www.yaohai-bio.com.cn/downloadfile
The document discusses various aspects of new product development for cosmetics, household, and insecticide products. It begins with an overview of the product development process and importance of satisfying consumer wants. Several examples of new product development are provided, including the development of a toilet bowl blue block and wardrobe insect repellent. Key steps in the process like ideation, product specifications, testing, manufacturing, and launch are covered. Trends in new product development like outsourcing and centralization are also summarized.
Maxheal Pharmaceuticals is an Indian pharmaceutical company with a vision to become a global player by 2015. It has experienced rapid growth since starting as a small retail pharmacy in the 1980s. The company exports pharmaceutical products to over 15 countries in Africa, Asia, and Latin America. In 2008, Maxheal acquired Ally Pharma, adding manufacturing capacity and approvals to sell in more African countries. Maxheal plans further expansion through an IPO and developing new product lines.
Power point presentation march 21 revisionteleprodirect
TelePro-Direct seeks funding to market Z Clear, a new Benzoyl Peroxide-free acne treatment. Z Clear uses patented technology from Columbia University to treat acne without the side effects of Benzoyl Peroxide. The $3 billion acne market is currently dominated by Proactiv, which uses Benzoyl Peroxide and causes skin irritation. Z Clear has the potential to capture significant market share by offering an effective alternative. TelePro-Direct has assembled an experienced team and developed a marketing plan to launch Z Clear through direct response advertising. They are seeking $1.2 million to fund marketing, production, inventory, and other launch expenses.
Procter & Gamble was founded in 1837 by William Procter and James Gamble. It originally produced candles and soap but pivoted to soap production for the Union army during the Civil War. Today, P&G operates across 180 countries and is organized into two global business units: Health and Well-Being and Beauty. Its largest segments are Fabric and Home Care, Beauty, and Baby Care and Family Care. P&G aims to acquire 1 billion new consumers by 2015 through expansion in developing markets and increasing productivity across operations.
Zhermack specializes in the production of materials and equipment for dental practices and dental laboratories, and provides its customers products whose trademarks are constant innovation and excellent quality.
Zhermack, undisputed leader in impression material production, was founded in 1981 and quickly positioned itself among the most important companies in the dental sector.
Besides its headquarters in Italy, Zhermack has branches in Germany, the United States and Poland and has Representative Offices in key locations such as Russia, United Kingdom, Spain, France, Mexico, Colombia and Turkey.
The widespread distribution network, with over 800 distributors worldwide, guarantees global sales coverage.
This document outlines a business plan for producing therapeutic proteins like vaccines and alpha-1 antitrypsin using tobacco plants. It discusses using tobacco's manufacturing capabilities to rapidly and cost-effectively produce proteins. Target markets include seasonal flu vaccines, pandemic flu vaccines, and alpha-1 antitrypsin for treating deficiencies. The plan involves outsourcing manufacturing activities and establishing partnerships with larger biotech companies and government organizations. Financial metrics like costs, pricing, and capital requirements are considered to evaluate feasibility and profitability.
Bio-Agro (Pvt) Limited has over 30 years of experience in agricultural products in Sri Lanka. They own over 12,000 acres of farmland and distribute a variety of products nationwide. For this analysis, we focused on their fruit juice offerings. Bio-Agro has a strong distribution network and loyal customer base due to their quality products and services. However, as a private limited company they face limitations in capital and expansion. Opportunities exist in receiving government support for agricultural products and a stable economy. Threats include weather-dependent supply and increased competition in the market.
This is a basic report of BEXIMCO pharma industry. Only basic tools and topics of management were used to prepare this report. This report might help the students who are doing MGT 210 COURSE in North South University of BANGLADESH.
Global Pharmas is a life sciences advisory firm serving the pharmaceutical and biotech industries. They deliver solutions for organizational effectiveness, branding, business development, and market entry. Their team has extensive experience in commercial roles. Global Pharmas represents clients seeking licensing deals for late-stage or commercialized products with differentiation. They identify opportunities, approach owners, and facilitate deals in key therapeutic areas like pain, respiratory, and dermatology.
Guavas originally come from the tropical regions of America.
The vitamin wealth of the guava is extraordinary. It is rich in vitamin C. It also contains pectin, provitamin A, vitamin B, iron, potassium and calcium.
Due to their high vitamin content, guavas have a preventive effect against colds.
In addition, they help with hyperacidity,
promotes digestion,
inhibit inflammation and
stabilize the immune system.
This document discusses coding technologies used to combat counterfeit pharmaceuticals. It describes overt coding methods like size, shape, and logos but notes these can be copied. Covert coding uses chemical or physical markers added invisibly. Regulatory barriers have hindered adoption of coding technologies but guidelines from the FDA have helped. Cost is also an issue, especially for generic drug makers. Future solutions may use nanotechnology and mobile phone verification to authenticate drugs for patients and ensure the correct personalized formulation.
Pharmacelera develops software and hardware solutions to accelerate drug discovery by finding better candidate molecules faster and in less time. Their technology includes a database of fragments and compounds with pre-computed descriptors, molecular simulation software that models interaction fields, and a computing platform with hardware accelerators. Pharmacelera has achieved strong growth since 2015 through international expansion and new technology releases. They are presenting at the President's Startup Challenge to gain recognition, mentorship, and advisory support to further accelerate their strategy and internationalization.
The document discusses ChromaDex's business model, which involves a legacy standards and analytical services business that provides market intelligence used to identify and acquire early-stage ingredient technologies. These technologies are developed and commercialized in multi-billion dollar markets like dietary supplements, food and beverage, cosmeceuticals, and pharmaceuticals. An example case study is provided on ChromaDex's acquisition, development, and commercialization of pterostilbene under the brand name pTeroPure, including a clinical study showing it significantly lowers blood pressure.
General Project is an Italian company that has designed and produced high-quality medical and aesthetic equipment for over 15 years. It employs 35 people in Florence, Italy and has two plants and a showroom. General Project aims to develop innovative technological products for body care and beauty to improve well-being. Its product range includes equipment for facial care, intense pulsed light therapy, laser therapy, microdermabrasion, and body contouring using ultrasound.
Similar to Genericlicensing.com - featured companies 2011 (20)
New Pharma Magazine is holding its launch party in New York City on March 14th during DCAT Week. The magazine is the premier source for news, events, and lifestyle insights for decision makers in the pharmaceutical industry. Key industry leaders such as Ed Borkowski and Stu Williams will attend the exclusive cocktail event at the W Hotel New York along with the president of Generic Pharma 2.0. New Pharma Magazine focuses on engaging readers on strategic issues facing the changing pharmaceutical industry.
The document is a promotional kit for co-exhibitors at a pharmaceutical licensing pavilion at a trade show. It highlights the benefits of exhibiting collaboratively at the pavilion such as increased networking opportunities and return on investment compared to exhibiting alone. It describes the location and facilities of the pavilion including private meeting rooms and networking areas. Floor plans of the pavilion layout are also included showing the arrangement of the different networking stations.
The document discusses challenges and opportunities in the development of biosimilars. It provides perspectives from several industry experts on the top hurdle being a lack of clarity around intellectual property and marketing strategies as well as high development costs. The experts note that developing the necessary skill sets around quality by design, analytics, and clinical trial design is key to overcoming hurdles in developing biosimilars safely and effectively.
Pfizer is facing significant challenges as many of its blockbuster drug patents expire in the coming years. This will open the door for cheaper generic competition that will eat into Pfizer's revenues. As CEO, I would [1] focus R&D on developing new blockbuster drugs to replace revenue losses, [2] look for strategic acquisitions of companies with promising drug pipelines, and [3] strengthen Pfizer's portfolio of treatments for chronic diseases to take advantage of demographic trends. With successful execution of these strategies, Pfizer could remain the world's most valued pharmaceutical company.
An article featured in our new New Pharma Magazine to be released in February. Stay tuned for details on how to subscribe to this cutting edge industry publication.
This document provides information on various over-the-counter licensing products categorized by therapeutic class and approval type. It includes summaries of cosmetic and medical device products for skin care, feminine hygiene, and fertility testing. Products like the Nanodermix Nanoanti-Age cream, nSkin wrinkle treatments, Esui feminine wash, Donna fertility tester, Donna Glove, and Multi-Gyn vaginal health products are highlighted.
This document contains 3 short summaries:
1) It summarizes statistics on how people access information online, with most using search engines and some using social media.
2) It summarizes statistics on people's concerns about data privacy when using different methods to access information online.
3) It summarizes statistics on how people recognize technology companies, with most recognizing Google and some recognizing other large companies.
The Magazine for Decision Makers in a Global Industry.
Look for the pre-launch edition coming in December 2011!
content@genericlicensing.com if you're interested in contributing editorial content, advertisement and/or advertorials.
Wörwag Research and Development GmbH is a subsidiary of Wörwag Pharma Group dedicated to developing generic, OTC, and new chemical entity products and medical devices according to European guidelines. Its business model involves licensing out its developed products in Europe and worldwide. The document provides readily compiled dossiers for several generic drug products that have received German and European marketing authorizations and are available for submission in other markets. It also outlines ongoing development projects and provides contact information.
This confidential presentation from Neogen in April 2011 discusses their API development and product selection process. Neogen develops and licenses out pharmaceutical products to generic companies wishing to expand their portfolios but lacking skills or willingness to undertake development. Their development process includes market intelligence, formulation, manufacturing facilities selection, regulatory strategy, and clinical testing for some products. They have first mover advantage on several products launched via various dosage forms developed both in-house and through production partners in Europe. Key personnel are introduced with relevant experience in the pharmaceutical industry.
This document is the 3rd edition of the Global Generic Product Directory, which contains information on generic pharmaceutical products and their developers. It has more products, developers, and data than previous editions. The directory aims to help users license generic products by providing contact information for developers. It can be accessed online for the latest product and company information. The founder of Genericlicensing Limited, which created the directory, encourages users to provide feedback on how to improve the resource.
Healgel is an innovative skin care gel developed by UK plastic surgeons to promote skin healing and reduce scar appearance. It contains ingredients that soothe, repair, and prevent scarring. A survey of 141 people found that 94% reported Healgel was very soothing, 82% had reduced swelling, and 85% found it highly effective at reducing discoloration. The gel's effectiveness comes from ingredients that stimulate collagen production, encourage cell renewal, seal the skin surface, and reduce itching and puffiness. Users reported the gel helped scars heal quickly and comfortably and reduced acne scarring.
This document summarizes a presentation about analyzing the biosimilars market. It discusses how interchangeability is a major hurdle for biosimilar uptake compared to generics. It analyzes growth statistics for the biologics market and shows it is concentrated in western markets, while most of the world's population is in developing markets. Future opportunities for biosimilars growth are seen in the US, EU, and India due to factors like pricing pressures and market entry barriers. Key therapeutic areas and where to invest are also discussed.
The document discusses a joint project between GlaxoSmithKline, GEA Pharma Systems, and Siemens to develop a continuous manufacturing solution for tablet production. The project was completed in just six months and proved that continuous manufacturing can produce tablets continuously and reliably with real-time quality monitoring. This approach uses significantly less space than traditional batch processes and improves manufacturing efficiency. The success of the project demonstrated that continuous manufacturing has potential to transform pharmaceutical production.
This document proposes a licensing-focused pavilion at the CPhI Worldwide Frankfurt trade show in October 2011. [1] The pavilion would promote licensing companies together to attract more clients than exhibiting individually. [2] Exhibiting in the pavilion would provide marketing and promotion for 12 months before and after the show as well as on-site support like catering and meetings with top clients. [3] Companies interested in the pavilion must be involved in licensing and book space soon as places are limited.
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
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Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfthesiliconleaders
In the recent edition, The 10 Most Influential Leaders Guiding Corporate Evolution, 2024, The Silicon Leaders magazine gladly features Dejan Štancer, President of the Global Chamber of Business Leaders (GCBL), along with other leaders.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
Explore the fascinating world of the Gemini Zodiac Sign. Discover the unique personality traits, key dates, and horoscope insights of Gemini individuals. Learn how their sociable, communicative nature and boundless curiosity make them the dynamic explorers of the zodiac. Dive into the duality of the Gemini sign and understand their intellectual and adventurous spirit.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
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Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
How MJ Global Leads the Packaging Industry.pdfMJ Global
MJ Global's success in staying ahead of the curve in the packaging industry is a testament to its dedication to innovation, sustainability, and customer-centricity. By embracing technological advancements, leading in eco-friendly solutions, collaborating with industry leaders, and adapting to evolving consumer preferences, MJ Global continues to set new standards in the packaging sector.
2. This is the 3rd ever edition of the
Global Generic Product Directory
We're really proud of this one. We've listened carefully to our community and made some changes. In this edition we have focused on presenting
our recommended developers. Too much choice can be paralyzing; so you will now a FEATURED DEVELOPERS section at the front. We have also
replaced 25% of the developers for one's we consider better partners for your business.
Remember that you can find the contact details for all the listed developers online and its costs you nothing to make an enquiry.
:
Find a product Go online to Make contact with
you like in the www.genericlicensing.com the developer
directory
Genericlicensing Limited has been set up to help you do more business, more effectively.
We understand the industry is changing. We understand that you want to find new value-added products for new markets. During 2011 we will
introduce new data for: Biosimilars, Super Generics & Over-the-Counter
We want to be the first place you turn to when you think about a new product
In order to better support you and your business, we are working hard to introduce more services online. You can now ask us to post WANTED
products online so the developers can come to you! Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!)
The world of generics at your fingertips!
Asa Cox
Founder, Genericlicensing Limited
asa.cox@genericlicensing.com
skype: asa_cox
Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of
the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
3. Contents
FEATURED DEVELOPERS
listed alphabetically
Antiobiotic ........................ 1
Astron ........................ 2 – 8
Aurobindo ........................ 9 – 13
BluePharma ........................ 14
Chanelle Medical ........................ 15 – 16
FamyCare Ltd. ........................ 17
Farmaprojects ........................ 18 – 20
Hikma ........................ 21 – 39
LogenexPharm ........................ 40
Lupin ........................ 41 – 44
Naari ........................ 45
Neogen ........................ 46
Orion ........................ 47
Rivopharm ........................ 48
Technimede ........................ 49 – 52
Wockhardt ........................ 53 – 59
Worwag ........................ 60
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
4. Research:
groups of patents.
Development: Approximately 50 products registered; about 20 further in
development.
Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled
manufacturing technology – including electronic batch recording.
Quality: and
transfer and inventory coverage.
Responsiveness: Global supply chain management services.
Marketing/ Distribution: Major generic player in UK and Israel; fully
We
geared up to win tenders in Germany. Presence in several more markets
target our goals. worldwide via distribution partners.
target our drugs. Interested in: Contract manufacturing Contract development/Co-development
time our delivery… Out-licencing In-licencing Distribution EU-re-analyses/ release
For more information please visit www.dexcel.com
because timing is everything Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
6. FEATURED DEVELOPERS Global Generic
Product directory
Antibiotic - Razgrad JSC, as the successor of the largest producer of antibiotics in Bulgaria. Balkanpharma-Razgrad JSC, has over 50
COMPANY NAME years experience in the development, production and sales of generic medicines for human and veterinary use. Antibiotic - Razgrad
Antibiotic JSC is the majority owner of Balkanpharma-Razgrad JSC - a pharmaceutical plant with production units for finished dosage forms:
capsules and tablets, semi-solid dosage forms, sterile liquid and dry injectable forms and also an industrial unit for lyophilized APIs.
The portfolio of products covers various therapeutic areas with an accent on infectious diseases, ophthalmology and dermatology.
CITY Antibiotic - Razgrad JSC has the necessary manufacture licenses and EU GMP certification for all productions and currently exports
Razgad to more than 25 countries in Europe and Asia. The development strategy of the company includes the implementation of modern
technologies and new products elaborated by its own R&D activities and is oriented towards expanding sales in international
markets. Apart from own market presence, the company is open to out-licensing and contract manufacturing projects.
COUNTRY
Core Sales Territory: Eastern Europe
Bulgaria Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing
Contact Person: Ms Gergana Semova; Managing Director
DOSSIER DOSSIER APPROVED REGULATORY
MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS
Betamethasone + Gentamicin Cream 1 mg + 1 mg CTD Ready Bulgaria PLG
Betamethasone + Gentamicin Ointment 1 mg + 1 mg CTD Ready Bulgaria PLG
Betamethasone Valerate Cream 1 mg / g CTD Ready Bulgaria PLG
Betamethasone Valerate Ointment 1 mg / g CTD Ready Bulgaria PLG
Dexamethasone Tablet 0.5 mg CTD Ready Bulgaria PLG
Fluconazole Injection - Solution 2 mg/ml - 50 ml, 100 ml CTD Ready Bulgaria PLG
Fluconazole Capsule 150 mg eCTD In-Dev Bulgaria
Fluconazole Capsule 200 mg eCTD In-Dev Bulgaria
Gentamicin Ointment - Eye 3 mg / g CTD Ready Bulgaria PLG
Hydrocortison + Chloramphenicol Ointment - Eye 5 mg/g + 2 mg/g CTD Ready Bulgaria PLG
Levofloxacin Injection - Solution 5 mg/ml - 50 ml CTD Ready Bulgaria PLG
Levofloxacin Injection - Solution 5 mg/ml - 100 ml CTD Ready Bulgaria PLG
Levofloxacin Drops - Eye 5 mg/ml - 5 ml CTD Ready Bulgaria PLG
Methylprednisolone Tablet 4 mg CTD Ready Bulgaria PLG
Methylprednisolone Tablet 4 mg CTD Ready Bulgaria PLG
Prednisolone Tablet 5 mg CTD Ready Bulgaria PLG
Prednisone Tablet 5 mg CTD Ready Bulgaria PLG
Tobramycin Ointment - Eye 3 mg/g CTD Ready Bulgaria PLG
Tobramycin + Dexamethasone Ointment - Eye 3 mg/g + 1 mg/g CTD Ready Bulgaria PLG
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 1
7. Global Generic
Product directory
FEATURED DEVELOPERS
Astron Research Ltd was established in the year 2001 with an objective to provide prompt and reliable services to Pharma sector
COMPANY NAME worldwide and improve the product quality with the help of Technological Innovations and Upgradations. Astron commenced its
Astron Research Ltd UK operations in 2004 for Quality Testing and QP Release of finished formulations and API. This facility is now UK-MHRA approved.
Astron Research Ltd has products and technology are sold in over 50 countries, which includes European Union, US, Canada Austra-
lia, New Zealand, South Africa, Brazil, Mexico, Middle East & North African countries. 18 ANDAs filed in US and 38 EU CTD dossiers
CITY developed till 2007. Astron Research Ltd is capable of handling Formulation and Analytical Research of Solid Orals, Injectables,
Ahmedabad Lyophilised injectables, Topicals, Effervescent tablets, Specialty medicaments like Potent drugs & Oncology products. The company
has also acquired expertise in oral NDDS and Controlled Release pellets.
COUNTRY Core Sales Territory: Global Regulated Markets
Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution
India Contact Person: Marc Comas, VP Business Development
DOSSIER DOSSIER APPROVED REGULATORY
Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS
Aceclofenac Tablet - Film coated 100 mg CTD Ready Spain PLG
Alendronate / Alendronic Acid Tablet 5 mg, 10 mg, 70 mg CTD Ready IOR PLG
Anastrozole Tablet - Film coated 1 mg ANDA Ready IOR NRP
Anastrozole Tablet - Film coated 1 mg CTD Ready IOR PLG
Aripiprazole Tablet - Dispersible (ODT) 5 mg, 10 mg, 15 mg, 30 mg CTD In-Dev N/A DCP slot booked
Aripiprazole Tablet - Dispersible (ODT) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg ANDA In-Dev N/A NRP
Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg CTD In-Dev N/A NRP
Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N/A NRP
Bicalutamide Tablet - Film coated 50 mg CTD Ready IOR PLG
Bicalutamide Tablet - Film coated 50 mg ANDA Ready IOR PLG
Bisoprolol Tablet 2.5 mg, 5 mg, 10 mg CTD In-Dev N/A DCP slot booked
Calcium Carbonate Tablet - Effervescent 500 mg CTD Ready IOR DCP underway
Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD In-Dev N/A NRP
Capecitabine Tablet - Film coated 150 mg, 500 mg CTD In-Dev N/A DCP slot booked
Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg CTD In-Dev N/A NRP
Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg ANDA In-Dev N/A NRP
Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) ANDA In-Dev N/A NRP
Carboplatin Injection 10 mg/ml (60 ml) CTD Ready IOR NRP
Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) CTD Ready IOR PLG
Cisplatin Injection - Solution 1 mg/ml (100 ml) CTD Ready IOR NRP
2 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
14. Global Generic
Product directory
FEATURED DEVELOPERS
Aurobindo Pharma was born of a vision. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in
COMPANY NAME key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardiovascular, gastroenterology, etc. Over the years, the Au-
Aurobindo robindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country
manufacturing facilities, and is becoming a marketing conglomerate across the world.
Aurobindo Pharma created a name for itself in the manufacture of bulk actives, its area of core competence. The formulation busi-
CITY ness is systematically organized with a divisional structure, and has a focused team for each key international market. Aurobindo
Hyderabad believes in gaining volume and market share in every business/segment it enters.
Core Sales Territory: Global Regulated Markets
COUNTRY Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution
India Contact Person: Mr Vivek Shah; Business Support Manager
DOSSIER DOSSIER APPROVED REGULATORY
MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS
Alendronate sodium Tablet 10, 70 mg; CTD Ready IOR IOR
Alendronate sodium + Cholecalciferol Tablet 70mg+2800IU, 70mg+5600IU CTD Ready IOR IOR
Alfuzosin HCl Tablet - XR 10 mg CTD Ready IOR IOR
Alfuzosin HCl Tablet 2.5mg CTD Ready IOR IOR
Alprazolam Tablet 0.25,0.5,1mg CTD Ready IOR IOR
Amisulpride Tablet 50, 100, 200, 400mg CTD Ready IOR IOR
Amlodipine Tablet 5&10 mg; CTD Ready IOR IOR
Amlodipine Capsule 5,10mg CTD Ready IOR IOR
Amoxicillin Capsule 250,500mg CTD Ready IOR IOR
Amoxicillin Tablet 1G CTD Ready IOR IOR
Amoxicillin + Clavulanic Acid PFOS 125+31.25, 250+62.5 mg: Sugar free CTD Ready IOR IOR
Azithromycin Suspension - Oral 200mg/5ml, 500mg/5ml* CTD Ready IOR IOR
Azithromycin Tablet 250/500/600mg CTD Ready IOR IOR
Benazepril Tablet 5, 10, 20mg CTD Ready IOR IOR
Betahistine Tablet 8,16,24mg CTD Ready IOR IOR
Bisoprolol Fumarate Tablet 1.25,2.5,3.75,5mg CTD Ready IOR IOR
Carvedilol Tablet 3.125,6.25,12.5,25mg CTD Ready IOR IOR
Cefixime Suspension - Oral 100mg/5ml CTD Ready IOR IOR
Cefixime Tablet 200,400mg CTD Ready IOR IOR
9 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
19. FEATURED DEVELOPERS Global Generic
Product directory
Bluepharma is a privately owned pharmaceutical company, based in Portugal. The main activities of the company include
COMPANY NAME development, manufacturing and marketing of generic products for human use.
Bluepharma Bluepharma has human resources and dedicated facilities allocated to R&D activities, covering formulation, development and
validation of analytical methods, scale-up, manufacturing of pilot batches, stability studies and regulatory affairs. Our company
is approved for the manufacturing and packaging of human investigational medicinal products. Starting in 2010 Bluepharma has
CITY the capacities to develop oncology products. The manufacturing site of the company exhibits a modern layout and is equipped
Coimbra with state of the art equipment for the manufacturing of solid dosage forms.
We account for a significant track record of successful developments, as well as for innumerous partnerships with top players in
the pharmaceutical industry worldwide, including USA.
COUNTRY
Core Sales Territory: Global Regulated Markets
Portugal Core Operation: Sales and Marketing, Finished Dose Manufacture, Distribution
Contact Person: Mr. André Garnel Freitas; Head of Business Development
DOSSIER DOSSIER APPROVED REGULATORY
MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS
Acarbose Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG
Aripiprazole Tablet 5 mg, 10 mg, 15 mg, 20 mg, 30 mg CTD Ready N/A NRP
Atorvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg CTD Ready Portugal IOR
Azithromycin Tablet - Film coated 500 mg CTD Ready Portugal PLG
Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD Ready Portugal PLG
Candesartan + HCTZ Tablet 8 mg + 12.5 mg, 16 mg + 12.5 mg CTD Ready Portugal PLG
Clarithromycin Tablet - Film coated 250 mg, 500 mg CTD Ready Portugal PLG
Clopidogrel Besylate Tablet 75 mg CTD Ready N/A IOR
Ibandronate / Ibandronic Acid Tablet - Film coated 50 mg, 150 mg CTD Ready N/A IOR
Irbesartan Tablet - Film coated 75 mg, 150 mg, 300 mg CTD Ready N/A DCP underway
150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mg
Irbesartan + HCTZ Tablet - Film coated CTD Ready N/A DCP underway
+ 25 mg
Levetiracetam Solution - Oral 100 mg/ml CTD Ready Portugal PLG
Levetiracetam Tablet - Film coated 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready Portugal PLG
Losartan Tablet - Film coated 12.5 mg, 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG
Losartan + HCTZ Tablet - Film coated 50 mg + 12.5 mg, 100 mg + 25 mg CTD Ready Portugal PLG
Nicorandil Tablet 10 mg, 20 mg CTD Ready Portugal PLG
Nimesulide Tablet 100 mg CTD Ready Portugal PLG
Pramipexole Tablet - Film coated 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD Ready Portugal NRP
Propiverine Tablet - Film coated 5 mg, 15 mg CTD Ready Portugal PLG
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 14
20. Global Generic
Product directory
FEATURED DEVELOPERS
The Chanelle Group was established in 1983 as a distributor of animal health products and is now the largest veterinary pharma-
COMPANY NAME ceutical manufacturer and distributor in Ireland. It diversified in 1980 into the development and manufacture of veterinary generic
Chanelle pharmaceutical products and is also a major player in the pet care market. A further diversification in 1995 with Chanelle Medical
been established as a developer & manufacturer of medical generic products.
Chanelle Medical are a one-stop-shop where we offer; formulation development, method development & validation, pilot batches,
CITY stability studies, monitoring of BE studies, compilation of dossier, registration of dossier, sale of dossier, manufacture and packing
Loughrea finish product. This company has approximately 900 generic product licenses (both Vet & Med) granted to date in 80 countries. The
Group is privately owned, has a turnover of €60m, 220 employees with it’s head office in Loughrea, Co. Galway and offices in UK,
France & Jordan.
COUNTRY Core Sales Territory: Western Europe
Ireland Core Operation: Sales and Marketing, Finished Dose Manufacture
Contact Person: Mrs. Chanelle McCoy; Director of Medical Business
DOSSIER DOSSIER APPROVED REGULATORY
Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS
Alkamed (Gaviscon) Solution - Oral 0.5% CTD Ready Ireland PLG
Amlodipine Capsule 5 mg, 10 mg CTD Ready Ireland PLG
Amorolfine Nail Lacquer 5% CTD Ready Ireland DCP underway
Atenolol Solution - Oral 25 mg / 5 ml CTD Ready Ireland PLG
Bisacodyl Tablet 5 mg CTD Ready Ireland PLG
Bisoprolol Tablet 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg CTD Ready Ireland PLG
Cefaclor Capsule 250 mg, 500 mg CTD Ready Ireland PLG
Cetirizine Solution - Oral 1 mg/ml CTD Ready Ireland PLG
Cetirizine Tablet 10 mg CTD Ready Ireland PLG
Citalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready Ireland PLG
Clindamycin Capsule 75 mg, 150 mg, 300 mg CTD Ready Ireland PLG
Doxycycline Capsule 50 mg, 100 mg CTD Ready Ireland PLG
DCP slot booked (Dec
Escitalopram Solution - Oral 20 mg/ml CTD Ready N/A
2011)
Exemestane Tablet 25 mg CTD Ready Ireland DCP underway
Fexofenadine Tablet 120 mg, 180 mg CTD Ready Ireland PLG
DCP slot booked (Dec
Frovatriptan Tablet 2.5 mg CTD In-Dev N/A
2011)
Glibenclamide Tablet 1.25 mg, 2.5 mg, 5 mg CTD Ready Ireland PLG
Glucosamine Sulphate Tablet - Film coated 500 mg (3x daily), 750 mg (2x daily), 1000 mg (1x daily) CTD Ready Ireland PLG
15 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)