Shilpa Pharma Lifesciences Karnataka facility clears COFEPRIS-Mexico GMP inspection
Karnataka: Shilpa Medicare has announced that the Company's 100% subsidiary, Shilpa Pharma Lifesciences Limited's Active Pharmaceutical Ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state has undergone a GMP inspection by COFEPRIS-Mexico from November 6-10, 2023.
Following a successful inspection, the Unit has been issued GMP Certification from COFEPRIS-Mexico.
The facility is involved in manufacturing various oncology and nononcology APIs.
"The company remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities," Shilpa Medicare said in a BSE filing.
Medical Dialogues team had earlier reported that Shilpa Pharma Lifesciences Limited's said facility had received GMP Certification from ANVISA-Brazil.
Read also: Shilpa Medicare arm Raichur API facility gets GMP Certification from ANVISA-Brazil
Shilpa is an integrated pharmaceutical group, headquartered at Raichur, Karnataka, India, with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with 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 CDMO customer reports positive results from Oxylanthanum Carbonate trial
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