Chemwerth - A Generic API Supply Company
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Chemwerth is an Active Pharmaceutical Ingredient or API Supply Company headquartered in Woodbridge, CT, USA. We provide generic pharmaceutical companies worldwide with safe and compliant ingredients for their finished dosage pharmaceuticals.
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Chemwerth - A Generic API Supply Company
- 2. The Business Objective 1. Company Overview 2. Why ChemWerth 3. Our Services 4. The Future – Industry & ChemWerth
- 3. To be a valued full-service global developer of Active Pharmaceutical Ingredients. • ChemWerth established 1982. • First-rate API Facilities Approved in 11 Countries. • Regulatory filings in 20 Countries. • 100+ Successful FDA Inspections in the past 10 years. • Over 30 approvals with no “form 483.” Company Overview
- 4. World Wide Customer Locations USA Headquarters in Woodbridge, Connecticut Shanghai, China Regulatory Office & FDA approved analytical laboratory Hyderabad, India Office • Freiburg, Germany Sales Office Canada United States Brazil Argentina Spain Austria Belgium Italy Greece Jordan United Kingdom Netherlands Germany Turkey Croatia Ukraine Russia Saudi Arabia India Australia Bangladesh Taiwan Japan Korea Switzerland Hungary Ireland Poland Armenia
- 5. Business Objective Why CWhy CHEMHEMWWERTHERTH?? High Quality API FDA Approved Factories Investing in Compliance Competitively Priced Confidentiality Agreements Fast to Market
- 6. Why ChemWerth – Fast to Market ● Over 200+ DMF Approvals. ● More than 45 First to Market generic approvals. ● Average 24 months in bringing new products to market.
- 7. Why ChemWerth - FDA Inspections Since 2009 52 Successful FDA Inspections: 18 Zero 483s, 34 Minor Deficiencies, & 0 Failures. 2011: 19 Passed, 7 Zero 483s. 2010: 10 Passed. 2009: 8 Passed, 1 Zero 483s. 2012: 5 Passed, 4 Zero 483s. 2013: 10 Passed, 6 Zero 483s.
- 8. What We Do – A Full Service API Supplier New Product Development New Product R&D, QA and Production Patent Review Services Compliance & Regulatory Support Customs & Logistics Support Product Launch Offering Full Service Support from product development to product launch.
- 9. New Product Development Team The Idea The Support The Process Product Evaluation •Competitive landscape •Identify manufacturer Patent Analysis •Intellectual Property Review •On-going Technical Support Stages of Development •Qualify Processes •PVB/Exhibit Batches
- 10. Regulatory and Compliance Team In house regulatory expertise •U.S. Team •China Team •Former FDA Inspector Six System Audit Program. 200+ DMFs filed. 150+ FDA Inspections. Past 5 years – 500+ regulatory filings in over 20 countries.
- 11. Supply Chain Management Skilled Project Managers All APIs meet RLD, ICH & FDA criteria Customs-Trade Partnership Against Terrorism (C-TPAT) & Dangerous Goods (DG) Certified Average 3 day customs clearance Offices in India, China & U.S. = Local logistics support
- 12. One World. One Quality ● International Marketplace. Local Inspections. ● GDUFA: FDA Approval Fees Imposed in USA ● EU Directive 62: Local Government GMP Certification ● FDA, WHO, EDQM: Must Meet all Regulatory Standards Your One Company. . . . ChemWerth ● Investing in GMP Compliance & Regulatory Documentation ● All API Partners are GDUFA Registered for 2014 ● Strong Industry Reputation – Done Right, the First Time
- 13. 30+ years FDA experience. All facilities cGMP compliant. APIs meet highest criteria. Impeccable inspection history. Recognized worldwide for compliance expertise. ChemWerth HQ 1764 Litchfield Turnpike Woodbridge, CT 06525
Editor's Notes
- Thank you for joining us. During this presentation we will be sharing a company overview of Chemwerth and how we can help your company.
- Specifically we’ll be reviewing Chemwerth’s history and industry track record. Why the biggest names in the generic pharmaceutical market choose to work with Chemwerth The services Chemwerth provides And lastly, what the future holds for our industry
- Chemwerth is a full service generic API development and supply company. Established in 1982 by Peter Werth, Chemwerth pioneered the development of generic APIs in China. Since then, Chemwerth has become one of the most trusted sources of API in the industry with API Manufacturing facilities approved in 11 countries Regulatory filings in 20 countries More than 100 FDA inspections in the last 10 years And over 30 approvals with zero 483s. Our expertise in working with overseas factories, our regulatory know how and ability to get things done right the first time has made Chemwerth an invaluable API supply partner for pharmaceutical companies worldwide.
- Today, we manufacture products in the U.S., Germany, India & China. Our customers enjoy the peace of mind in knowing that ChemWerth’s superior technical and regulatory services ensure that their API’s are non-infringing, cGMP compliant, and ready to go to market.
- So why is Chemwerth the industry’s “go to” supplier of generic APIs? Well, with a highly skilled staff of regulatory specialists, Chemwerth knows how to achieve and maintain compliance. We work directly with our partner factories - investing time and money in getting them up to FDA standards and maintaining that standard. With over 30 years of experience and a longstanding relationship with the FDA, Chemwerth understands the value of a high quality API manufacturer and will only work with the best. All of our factories are cGMP qualified and FDA approved to ensure your Finished Dosage is safe and effective and will meet all global standards.
- With a 24 month average launch time, you will feel confident of a timely approval when using ChemWerth as your API supplier. We have facilitated well over 200 generic finished dosage approvals in the past 10 years alone. Our ability to work with a high degree of confidentiality and navigate through tough issues has led to more than 45 First to Market launches giving you the competitive advantage you need to dominate the market. At the end of the day, you will have confidence that your product will reach market targets when you work with ChemWerth.
- Just in the last 5 years, Chemwerth has had 52 FDA inspections. All 52 passed inspection. 18 of those 52 passed with zero 483s and the remaining 34 passed with minor deficiencies. Which is a very strong compliance record in today’s FDA environment. This is why companies like yours choose Chemwerth first.
- As a full service API development and supply company with over 30 years of experience, ChemWerth is your one stop shop from new product development to product launch. Chemwerth is your “behind the scenes” company; all of our teams work in unison with one purpose in mind – a successful product launch for your company.
- The foundation of your success begins here – Chemwerth’s new product development team. Our highly qualified scientists and market researchers provide product selection and evaluation services based on your marketing strategy that cover market research, patent assessment, competitor analysis and factory selection. We then work closely with API partner manufacturers to successfully develop products from conception to commercialization to ensure your success. .
- Chemwerth’s #1 goal is to get your product to market. Our experience, knowledge, and good working relationship with the FDA help us expedite the approvals needed to get you there fast. Our Regulatory team manages documentation creation, review and submission. While, our Compliance team, headed up by a former FDA Inspector, manages facility compliance and inspections. Our Six System Audit Program mirrors the FDA inspection process so we are more prepared for the real thing. Under Six System, Chemwerth routinely audits our factories not only in preparation for an FDA inspection but on an on-going basis. The results of every audit are written up in a corrective action plan and we follow up with the factory to make sure the corrections have been made so compliance is maintained 365 days of the year. The implementation of this program in 2010 has led to a 45% increase in zero 483 results. Chemwerth’s close association with our represented manufacturers enables us to respond quickly and reliably to all aspects concerning regulatory submissions, cGMP issues, quality assurance issues and technical service requests.
- Our expert logistics team staffed with skilled project managers are there on the front end AND the back end to ensure the quality of starting materials, supply chain security and ultimately, on time delivery. We work with all vendors, internal departments and customers to eliminate unnecessary delays of your API. Our C-TPAT and DG certifications along with our understanding of the local processes make doing business with Chemwerth safe and efficient.
- With the globalization of our industry, we are no longer buying and selling within local markets. Advancements in technology has broadened our reach around the world. Constantly evolving regulations like GDUFA and EU Directive 62 are forcing a higher standard on companies that want to enter the US and European regulated markets. Your company's success is becoming increasingly more reliant on the quality and follow through of your API supplier. You need a supplier that has an understanding of these changing guidelines, the financial stability to follow through on GDUFA fee obligations, DMFs Available for Reference and a commitment to regulatory compliance and product excellence. Chemwerth does all of this and more.
- Over 30 years FDA experience cGMP Compliant facilities High quality API Unmatched inspection history Recognized as the go to compliance experts And a ‘One World-One Quality’ approach that is the back bone of everything we do, every decision we make; making Chemwerth the ‘One Company’ for your API needs. We know how to get things done the first time, the right way – from the initial stages of your product selection to the final product launch – Chemwerth will get you to market fast. Thank you for your time and we look forward to doing business with you.