Shilpa Pharma Lifesciences gets CEP from EDQM for API, Octreotide
Karnataka: Shilpa Medicare has announced that the Company’' 100% subsidiary, Shilpa Pharma Lifesciences Limited has received a certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Octreotide.
Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis.
Acromegaly, severe diarrhea/flushing episodes associated with metastatic carcinoid tumors, profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors. Octreotide is second peptide molecule in Shilpa’ s peptide portfolio.
Read also: USFDA accepts Shilpa Medicare CDMO partner Unicycive NDA for Oxylanthanum Carbonate
Medical Dialogues team had earlier reported that Shilpa Medicare CDMO partner Unicycive Therapeutics, Inc. had announced that the U.S. Food and Drug Administration (USFDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and had set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Read also: Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin
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