Since our inception, manufacturing has been our forte. We have inculcated the latest in advanced manufacturing techniques while conforming to the industry standards.
Alembic has 3 Manufacturing plants for the API. All the 3 facilities are cGMP compliant and catering to the API requirements of the Regulatory markets. The facilities have been audited and approved by the major Regulatory bodies of Globe, viz:- USFDA., European authorities, KFDA, ANVISA, COEFEPRIS, etc.
Alembic prides itself in its World class Research facilities. The API RND center comprises of 150+ scientist (Chemical research/Analytical/Patent) working on the Generic API development. Major focus is on early development of molecules & development of Non infringing processes which will enable customers to go for early launch possibilities.
Regulatory is our strength area. With a team of 14 people in the API regulatory department, we endeavor to provide a timely support for all the filings of our customers and supporting them through the Regulatory approval process and ultimately the lifecycle of the product. Currently, we have a total of 84 submitted USDMFs, 34 CEP granted by EDQM, 5 filed JDMF (with a pipeline of 10+ more DMFs in the next 12 month period, 20 filed IDL in China(with additional pipeline of atleast 15 more for next 12 months), 22 approved DMFs in South Korea and 25 approved products with COEFEPRIS, Mexico.