This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.

1. Dr. B. GURUSWAMY
Mobile: +91-9160770033 • Email: guruswamy2748@gmail.com
Address: Flat No. 403, Sri Sai Chandra Residency, Madhavi Nagar, Bhagyanagar Colony, Kukatpally, Hyderabad – 500074
API RESEARCH/ PROCESS DEVELOPMENT/ LIFE CYCLE MANAGEMENT
EXECUTIVE SUMMARY
• Ph.D. (Synthetic Organic Chemistry) and honed with over 17+ years diversified industrial research exposure on API’s
Research, Product Development, Scale up and Ongoing products Life Cycle Management in the Pharmaceutical
Industry.
• Currently associated with Neuland Laboratories, Hyderabad as Senior Principal Scientist- R&D.
• Deft in process development, optimization, validation, scale-up, prompt re-dressal of trouble shootings and life cycle
management of ongoing products.
• Capable of handling multiple projects with spearheading team of scientists and monitoring development activities
with respective cost, resource deployment, time over-runs and quality compliances.
• Well organized, diligent and detail-oriented with fine tuned analytical and problem solving skills. Effective team
leader, trainer and motivator with ability to build and retain teams of performers. Superior verbal and written
communication skills.
CORE COMPETENCIES
• Literature search • Route scouting • ROS Design • IP creation • Design of Experiments in QbD concept • Design of
specification • Identification of CPP and CQAs • Impurity synthesis • Risk assessment (quality & process) • Genotoxic
impurities assessment and control strategy • Process validation • Documentation • Technology transfer/ Scale up
• Regulatory support for filings • Dealing with customers • Multiple projects management • Effective resource utilization
• Customer communication and complaints handling • Process improvements/Life cycle management • Cost reduction
and troubleshooting • Training and development.
CAREER CONTOUR
Neuland Laboratories, Hyderabad Since Sep’04 - Till date
Growth Path:
Senior Principle Scientist (Deputy General Manager) Apr’15 – till date
Principal Scientist (Assistant General Manager) Apr’13 – Mar’15
Senior Manager Apr’11- Mar’13
Manager Apr’09 – Mar’11
Deputy Manager Sep’04 – Mar’09
KEY RESPONCIBILITIES
 To lead literature search and identifying suitable route and mounting non-infringing process for API and
intermediates.
 Effective process development for creating commercially viable, eco-friendly process for API’s and intermediates.
 Oversee the end to end synthesis of an API’s from lab scale to Commercial Scale.
 Key role in design of experiments (DOE) based on QbD concept.
 Lead and motivate a team of 20 experienced research scientists with multiple labs/ projects. Oversee day to day
research activities and guide the team to increase the productivity.
 Work with innovator companies on their NCE molecules to further improving the quality and cost.
 Work with Contract manufacturing facilities in abroad and demonstrate the process to them at their sites to
commercialize the product and continuous manufacturing.
 Take challenges of trouble shooting and improve efficiencies of ongoing products.
 Identification of cost reduction areas and execution for existing products to increase the life cycle management of
products.
 Dealing with customers on quality and regulatory related issues.
 Review the specifications for RM’s, intermediates and coordinating with SCM/supplier to get right materials.
 Leading the team among CFT as a Single Point of contact for coordination from project development to scale up,
regulatory filings.
 Monitoring the project development/progress through critical chain project management (CCPM) and facilitate to
complete the project in time to make win-win situation to customer as well as own organization.

2.  Promote the interchange of ideas, concepts and history of process development in various aspects, from theory to
hardware
 Provide a continuous forum for communication, sharing ideas, learning new concepts and benchmarking.
 Promote networking and communication among those involved in process development
 Inter departmental (analytical, IP, Regulatory, SCM, marketing & Manufacturing) support on customer and regulatory
quarries.
 Effectively planning and managing resources to address overall and specific project needs.
 Contributing to resource planning (financial and personnel) for assigned projects within the function and performing
periodic laboratory audits.
 CARRIER HIGHLITES
 Products Handled / Developed: 29
 Products DMF Filed: 19
 Products under development/ DMF plan to be filed: 5
 Cost Reduction Projects handled: 10
 Granted Patents: US - 6
 Granted patent in Europe-5
 Patent Applications In various Stage: 11
 International Publications: 6
 Non-infringing process developed for an antipsychotic agent and commercialized including sterilization (sterilization
process carried out at CMO facility in Europe) which became a high through put product for the organization.
 The New and commercially viable process developed for gamma cyclodextrin derivative, Neuland is only manufacture
for this product after innovator.
 High quality and cost effective process developed and, tied up with innovator and launched the product commercially.
 Received certificate of appreciation from Innovator Company for developing and scale up safe, cost effective process
with (high purity, low cost than innovator) for their NCE molecule.
 Five US and Europe granted patents in credit along with other nine international publications are active which are in
different stages of examination.
PATENTS/ PATENT APPLICATIONS
 US 8,907,083, EP2632907 B1
 US 8,940,749, EP2683717 B1
 US9199916, EP2776388 A1
 US9199933, EP2855432B1
 US9120876, EP2609120 B1
 US9296705, EP2890694 A1
 WO2014009966, EP2872500 A1
 WO2014125501
 WO2013080220
 WO2013132514
 WO2011121595
 WO2011051957
 WO2009084030
 WO2009084031
 PCT/IN2014/050006
 2339/CHE/2015
Dr. Reddy’s laboratories Ltd., Hyderabad, India Nov’98 - Sep’04 (~ 6 years)
Growth Path:

3. Executive Apr’03 - Mar’04
Officer Apr’99 - Mar’03
Trainee chemist Nov’98 - Mar’99
KEY RESPONSIBILITIES
 Literature collection and route scouting.
 Design the laboratory experiments, execution and report preparation.
 Performing the laboratory experiments and interpretation of analytical data of laboratory experiments to draw the
conclusion and plan for next experiments.
 Spearheaded a team of 6 scientists and day to day reporting immediate supervisor.
 Interpretation of analytical data of laboratory experiments.
 Impurity synthesis and characterization to support customers need and internal use.
 Reference standards, working standards preparation and qualification.
 Cost reduction and troubleshooting for commercialized products.
 Actively held discussion with analytical chemists and DQA on analytical results and specifications.
 Played key role during the process validation in plant, co-ordination with manufacturing, T.T and quality.
ACADEMIC CREDENTIALS
Ph.D. (Synthetic Organic Chemistry); 2014
Department of Chemistry, Jawaharlal Nehru Technological University (JNTU), Hyderabad, India.
Thesis Title: Synthesis and biological evaluation of novel 7- Substituted fluroquinolones.
M.Sc. (Organic Chemistry); 1998
Swamy Ramananda Teertha Maratwada University, Nanded, India
B.Sc. (Chemistry, Botany and Zoology); 1995
Osmania University, Hyderabad, India
RESEARCH UNDERTAKEN
 Fluoro-quinoline class of antibacterial compounds are having number of advantages over other class of antibacterial.
Ph.D. work is carried out strategically designed and modified novel 7- substituted fluoroquinolones starting from its
quinolone carboxylic acid in multiple steps with good yields and acceptable purity. The mechanistic aspect of all the
reactions has been thoroughly studied and all the synthesized compounds were well characterized by IR, 1
HNMR, 13
C
NMR, Mass spectrum and elemental analysis data. Carried out the synthesis using conventional and microwave
irradiation technique to establish environmentally benign process. All the synthesized compounds were screened for
their anti microbial activity by in vitro studies and found some of the compounds exhibited more or comparable
activity with standard drugs.
 Synthesized and characterized about 75 novel fluoroquinolone derivatives and conducted antibacterial and antifungal
biological activity in-vitro.
 Developed oxidizing reagent i.e. Hydrogen peroxide in titanium tetra chloride for effective oxidation of sulfides from
corresponding sulfones which free from sulfoxide.
 Synthesized various fluroquinolones with excellent activity than approved API’s.
PUBLICATIONS
 Synthesis and anti-microbial evaluation of substituted benzimidazolyl Fluoroquinolones under conventional and
microwave irradiation conditions” B. Guruswamy & R. Arul, Heterocyclic Comm., 4, 2012, 203- 206.
 Synthesis, Characterization, Antimicrobial Activity of Novel N-Substituted β-Hydroxy Amines and β-Hydroxy Ethers
Contained Chiral Benzoxazine Fluroquinolones”, B. Guruswamy & R. Arul, Letters in Drug Design & Discovery, 10,
2013, 86-93.
 Synthesis and Antimicrobial evaluation of novel n-substituted β-hydroxy benzimidazole sulfone fluoroquinolones by
selective oxidation using TiCl4 catalysed H2O2. ” B. Guruswamy & R. Arul, Phosphorus, Sulfur, and Silicon and the
Related Elements, 188, 2013, 1205-1213.
 Synthesis, Characterization and Antimicrobial Activities of Novel N-substituted β-hydroxy Amines and β-Hydroxy
Ethers Contained 8-methoxy Fluoroquinolones” B. Guruswamy & R. Arul, J. Het. Chem., (DOI. 10.1002/jhet.1927).
 Design, synthesis and perform Antimicrobial Evaluation of Novel Tricyclic Benzoxazine Fluoroquinolones under
Conventional and Microwave Methods. B. Guruswamy & R. Arul, J. Het. Chem., 52, 532, 2015.
 “Synthesis and biological evaluation of novel β-hydroxy benzimidazolyl sulfone fluoroquinolones by selective
oxidation using ammonium molybdate catalyzed H2O2. B. Guruswamy & R. Arul, European J. Chem., 4 (4), 2013, 329-
335.

4.  “A micro-wave assisted synthesis of benzimidazole derivatives using solid support” B. Guruswamy* & R. Arul, Der
Pharma Chemica, 3 (6), 2011, 483-486.
PARTICIPATIONS
 Participated in the second International conference on “Organic synthesis and process Chemistry” at IICT, council of
scientific and Industrial Research. Hyderabad.
 Attended International conference on “crystallization, filtration and drying” at UDCT, Matunga, Mumbai.
 Attended international conference on “Intellectual property management in pharmaceutical industry” University of
Nagapur, Nagapur, Maharastra.
 Became a part of the national workshop on “Design of Experiments for Scientists and Engineers” at IICT, HRDC, council
of Scientific and Industrial Research, Hyderabad.
 “Green Organic Synthesis in Pharmaceutical on over view” at Siddhartha Academy of General and Technical
Education, Vijayawada.
 “Synhydride Symposium” at ITC Hotel, Kakatiya Sheration, Hyderabad.
 Attended the 5th
BASF Boron Conference” from Lab to Launch-Discover New Horizons’, HICC, Hyderabad.
Date of Birth: 02.03.1973
References:
1. Dr. R. Arul Vice-president, Head- R&D, Ind- swift laboratories, Mohali, Chandigarh, Mobile No. +91 8283001205 e- mail:
r.arul@indswiftlabs.com
2. Dr. Gobind Singh Kapkoti, Vice-precedent – R&D, Intas laboratories, Ahmadabad, mobile No. +91 9712957844 e- mail:
gobindsinghkapkoti@intas.com
3. Dr. N. Praveen Kumar, Associate Vice-President, Neuland laboratories, Hyderabad, Mobile No. +91 8886504499 e- mail:
npraveenkumar@neulandlabs.com