Shilpa Medicare receives Europe GMP Certification for Hyderabad facility
Gadwal Hospital Inspection
Karnataka: Shilpa Medicare has received the Good Manufacturing Practice (GMP) Certification after the successful closure of the EMA, Europe inspection at Unit 7, Nacharam, Hyderabad, Telangana, India.
The inspection was conducted from 24th to 26th September 2024.
"This is to inform you that the Shilpa Medicare Limited, Unit 7, Nacharam, Hyderabad, Telangana, India had completed an inspection from EMA, Europe from 24th to 26th September 2024," the Company stated.
Shilpa Medicare Limited, Unit VII, has an Analytical Services Division (QC) and a Bio Analytical Department. Both laboratories are approved by USFDA. The Bio-Analytical Laboratory is already approved by EMA, Europe.
This inspection was a Europe inspection for the QC laboratory of Unit VII. This Laboratory is involved in testing drug substances, raw materials, packing materials and finished products. It is also engaged in other analytical activities like analytical method validations, method transfers and other miscellaneous analytical studies. The laboratory has been testing samples for final release into US, EU and other markets.
Medical Dialogues team had earlier reported that the Company's Joint Venture Oncosol (50:50 JV with Liqmeds Lifecare Limited, a Zydus group company and Koana Healthcare Limited, Shilpa Medicare group company) along with its partner Shorla Oncology had received the approval from the US Food and Drug Administration (USFDA) for IMKELDI (imatinib oral solution), a oral liquid form of imatinib to treat certain forms of leukemia and other cancers.
Read also: Shilpa Medicare-Zydus JV gets USFDA nod for Imkeldi for certain forms of leukemia, other cancers
Shilpa is an integrated pharmaceutical group 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.
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