Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin

Karnataka: Shilpa Medicare Limited's 100% subsidiary, Shilpa Pharma Lifesciences Limited has received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Desmopressin.

Desmopressin is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis. Desmopressin helps to reduce frequent urination and excessive thirst. This is used to treat central diabetes insipidus and bedwetting.
“We at Shilpa have always been investing in challenging chemical synthesis. With unwavering commitment and belief in our technical capabilities, we have invested in developing a versatile peptide portfolio over past few years and Desmopressin is the first peptide molecule to receive CEP from the European Regulators. This CEP showcases our proficiency in quality-oriented development as well as commercial manufacturing capabilities that meet the expectations of global quality standards paving way for more such products to follow”, said Mr. Keshav Bhutada, Executive Director- Shilpa Pharma Lifesciences Limited.

Read also: Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics

Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Nononcology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.

Read also: Shilpa Medicare gets USFDA nod for Bortezomib Injection for multiple myeloma




from Medical News, Health News Latest, Medical News Today - Medical Dialogues | https://ift.tt/XeELJ5s

0 Comments