From our modern facilities, teams of highly trained and qualified staff provide a wealth of experience to ensure high quality service is provided throughout the manufacturing process. In India, our oral solids facility has been approved by the EMEA
and is ready for USFDA certification. In Sweden, the facility has been inspected by USFDA, EMEA and Japanese regulatory authorities.
|Home | Quality|
|Quality - the foundation of success|
Kemwell meets current Good Manufacturing Practices
(cGMP) as per International Quality Guidelines and continues to invest in people, processes and equipment to ensure that Kemwell remains a quality leader in every aspect of our business. Our Quality System is the
foundation of our operations and through comprehensive SOPs, rigorous training and a range of process controls, we ensure that all products meet the highest quality standards.
|The Quality System|
|Committed to quality compliance|
|The Company is dedicated to strict cGMP compliance and the methods, facilities and controls used for the manufacture, processing, packaging and holding of all finished pharmaceuticals produced at Kemwell are in accordance with the applicable sections of cGMP regulations. A continuing employee training program, equipment and process validation, and a self-inspection program are part of our commitment to quality assurance. The entire company is committed to an ongoing quality improvement process. Special emphasis is placed on thorough documentation and review of the entire manufacturing and control process. The documentation system and customized batch documents assure that requirements have been m
Our experienced QA staff can provide quality assurance support and auditing for your internal or contracted studies. Our staff is experienced in auditing internal and external studies to assure compliance with GLP and/or GMP, as appropriate. They can also provide assistance in establishing new compliance programs.
Quality - the foundation of success:
Kemwell meets current Good Manufacturing Practices (CGMP) as per International Quality Guidelines and continues to invest in people, processes and equipment to ensure that Kemwell remains a quality leader in every aspect of our business. Our Quality System is the foundation of our operations and through comprehensive SOPs, rigorous training and a range of process controls, we ensure that all products meet the highest quality standards.
The Quality System:
Committed to quality compliance:
The Company is dedicated to strict cGMP compliance and the methods, facilities and controls used for the manufacture, processing, packaging and holding of all finished pharmaceuticals produced at Kemwell are in accordance with the applicable sections of cGMP regulations. A continuing employee training program, equipment and process validation, and a self-inspection program are part of our commitment to quality assurance. The entire company is committed to an ongoing quality improvement process. Special emphasis is placed on thorough documentation and review of the entire manufacturing and control process. The documentation system and customized batch documents assure that requirements have been met. These documents are reviewed and updated as necessary to maintain quality standards.
“Quality is an important part of almost all projects. We add value across the entire production chain, from buying the raw materials until the finished products leave the plant. What feels best is when we succeed with improvements, resulting in better operations".
Ensuring quality control from raw materials to the final products:
Kemwell has facilities and personnel to perform full service in-house quality control testing. Test methods include wet chemical and instrumental analyses, and microbiological evaluations.
Our Laboratories are equipped for:
Design and manage comprehensive stability studies to ICH guidelines.
“Kemwell’s foundation is built on integrity, respect and responsibility towards our customers, employees, associates and the entire community in which we live and work. Without upholding our moral standards, our successes would amount to nothing.”
Services We Offer
Contract CMC Services: Formulation Development to Commercial Manufacturing
Celebrating 30 years as a contract pharmaceutical manufacturer, Kemwell’s success is the result of unwavering commitment to delivering 100% customer satisfaction. We understand that in today’s competitive climate, it is not enough to claim Quality, Expertise, and Capability. These characteristics are expected!
At Kemwell, we know that Communication, Speed, Flexibility & Trust are key to a successful, long term client-contractor relationship. As a proven provider since 1980, it is all about meeting our commitments to each and every customer. This is what separates Kemwell from the plethora of contract providers, and has won Kemwell “the Best Contract Manufacturer in India” per customer survey, sponsored by OPPI (Organization of Pharmaceutical Producers in India).Today, Kemwell is committed to growing with our customers. We have strategically invested in providing solutions in-line with our customer’s goals. These investments include new pharmaceutical equipment & facilities to support early drug development, clinical supply services, commercial manufacturing, and biologics manufacturing.
Board of Directors
Anurag BagariaAnurag Bagaria is the Chairman and MD of Kemwell. Anurag is responsible for managing and driving Kemwell’s performance, formulating and executing long-term strategies, and leading the company’s business operations globally. He is committed to developing strong customer relationships, with a passion for building Kemwell’s delivery capabilities, and a disciplined focus on operations and execution.Anurag joined Kemwell in 2004 as a second-generation entrepreneur and became Chairman in 2010. He holds a degree in Chemical Engineering from Cornell University and an MBA from Kellogg in the US.PerÅke OldentoftMr. PerÅke Oldentoft joined the Board of Kemwell India in 2005 and the Board of Kemwell Sweden in 2006. He served as the CEO of Kemwell Sweden from 2006 to 2007. Perake has over 35 years of managerial experience in Life Science in companies like AstraZeneca, Pharmacia, Ferrosan, Gacell and QPharma as CEO and in international sales, marketing, production and product development.Rolf WernerProf. Dr. Rolf G. Werner was Corporate Senior Vice President of the Corporate Division Biopharmaceuticals at Boehringer Ingelheim GmbH and was responsible for the strategic orientation and the worldwide business of biopharmaceuticals before he retired in 2011.He obtained his M.Sc. in biology at University of Tübingen in 1971. After his scientific work at the Max-Planck Institute for Molecular Genetics in Berlin he obtained his PhD at University of Tübingen in 1973.In the same year he joined Boehringer Ingelheim at the Department of Biological Research and has been involved in antibiotic research. After a sabbatical in 1978 at the Massachusetts Institute of Technology in Cambridge, USA, he returned to Boehringer Ingelheim and became Head of Biopharmaceutical Manufacturing.In 1990 he was appointed as professor at the Faculty of Biology at the University of Tübingen. He is member of the scientific board of the University of Stuttgart and the Fraunhofer Gesellschaft, member of the editorial board of the journal Drug Research and expert agrée for registrations of pharmaceuticals in France.From 1998 to March 2000 he was head of the Industrial Biopharmaceutical Department at the Boehringer Ingelheim GmbH and therefore responsible for the development and manufacturing of biopharmaceuticals at various sites of Boehringer Ingelheim. According to the importance of this growing business this department became Corporate Division and Prof. Werner was promoted as the Corporate Senior Vice President in March 2000.S.R. ChandakS.R. Chandak is the Finance Director of Kemwell. He has been with Kemwell for over 20 years and has a wide experience in finance, accounts, taxation, company law, legal, MIS and active participation in joint ventures. He has completed his B.Com, LLB from Calcutta University and a Diploma in Business Administration from St. Joseph’s College, Bangalore.Strategic AdvisorShabbir Anik, Ph.D., MBADr. Anik is an experienced executive in the biotech, pharmaceutical and contract services industry, with expertise in drug development, drug delivery, pharmaceutical technology, operations management, and business leadership. He is currently Sr. VP, Technical Operations at Onyx Pharmaceuticals. He has held several senior management positions including VP, Program Management at Syntex, President, Pharmaceutical Development Services at Patheon, and CEO, Althea Technologies.He is the founding president and former board member of the non-profit organization EPPIC, and Charter member of TIE, a global organization fostering entrepreneurship. He is also the Chairman of Valgenesis, a software company. He has been an invited lecturer on Technology Transfer in the Berkeley Drug Development course.
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