At the recent 2013 Interphex meeting in New York City. Christian Ahlmark spoke to Outsourcing Pharma regarding recent Kemwell news, including the most recent FDA Inspection and approval, the new opening of the Biopharmaceutical manufacturing site (supporting biosimilar manufacturing and aseptic fill finish) in Bangalore India, and the new facility expansion plans in the USA, supporting formulation development and analytical testing services.
April 17th 2012
Kemwell announces the expansion of its new Pharmaceutical Development labs:
Kemwell Biopharma Pvt. Ltd., an India-based formulations contract manufacturer, has expanded its state-of-the-art pharmaceutical development labs in Bangalore, including a 7,500 sq. ft. cGMP pilot facility to support pharmaceutical projects from pre-formulation to finished products.
“We are seeing an increasing demand for contract development services in the global market. Kemwell has invested in a world-class facility with experienced scientists to meet the growing needs of its customers. With the new labs, Kemwell continues to build upon its ongoing commitment to be a high-quality one-stop shop service provider for its customers,” said Anurag Bagaria, Managing Director.
The 15,000 sq. ft. facility has capabilities to handle solids, injectables (large and small molecules), liquids and semi-solids dosage forms. Currently, the labs have 80 scientists with the ability to scale up to 150 scientists. Our scientists have extensive expertise in developing formulations for conventional and specialized dosage forms, including sustained release (SR) and modified release (MR) solids, liquids, and injectables.
Kemwell has the capability to offer customers pharmaceutical services that include pre-formulation, formulation development, analytical method development and validation, process optimization and scale-up, packaging development, pivotal batch manufacturing, stability batch manufacturing, stability studies, clinical batch manufacturing, labeling for blinded studies, preparation of placebo batches, tech transfer as well as commercial manufacturing. This enhanced facility coupled with our commercial manufacturing network on the same site, enables Kemwell to offer a wider scale of services for the development, testing and commercialization of large and small molecules. In Sweden, Kemwell also provides services for QP release. Says Anurag Bagaria, “Kemwell’s sites in India and Sweden can work in harmony to provide the customer with the best solution from both worlds”.
About Kemwell Biopharma Pvt. Ltd:
Bangalore-based Kemwell Biopharma Pvt. Ltd. (www.kemwellbiopharma.com) is a leading provider of formulations contract development and manufacturing services for multinational pharmaceutical companies for 30 years. From facilities in India & Sweden, Kemwell manufactures tablets, capsules, liquid orals, external drops, ointments, gels and creams. Kemwell’s customers include 5 of the top 10 pharmaceutical companies in the world. With 100% commitment to pure play contract manufacturing, Kemwell has no branded products of its own in the market, thereby avoiding any conflict of interest with its customers. Kemwell has recently built a new state-of-the art biologics manufacturing facility in Bangalore in collaboration with Boehringer Ingelheim to offer process development and cGMP manufacturing services for drug substance and drug product.