By: IPP Bureau
Last updated : November 02, 2024 10:15 am
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru, India was inspected by USFDA between 24-30 October 2024. The inspection was the onsite GMP inspection of this site.
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature. The company shall respond to the observations within the time frame.
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 a carefully crafted biological portfolio.
Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its strong R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.