Shilpa Medicare gets four USFDA observations for Bengaluru facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-11-04 10:28 GMT | Update On 2024-11-04 10:28 GMT

Raichur: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has issued Form 483 with four observations at the conclusion of the inspection at Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru, India.

The facility was inspected by USFDA on 24, 25 and 28, 29, 30 October 2024. The inspection was the onsite GMP inspection of this Site.

All observations are procedural in nature.

"The Company shall respond to the observations within the time frame," the Company stated in a BSE filing.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

This Unit of Shilpa Medicare Ltd. is engaged in the manufacturing, testing and release of Oral Mouth Dissolving Films and Transdermal Systems. The Site has already been approved by MHRA-UK and TGA Australia and has USFDA approval for supplying nutraceutical Oral Film products into US and other markets.

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 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 its R&D units and seven manufacturing facilities.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Shilpa Medicare gets four USFDA observations for Bengaluru facility

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