The U.S Food and Drug Administration (USFDA) has concluded inspection at Shilpa Medicare’s Unit VI, Dabaspet, Bengaluru, India. The inspection concluded with the issuance of Form 483 with four observations. All observations are procedural in nature. The company shall respond to the observations within the time frame. The said unit was inspected by USFDA on October 24, 25 and 28, 29, 30, 2024. The inspection was the onsite GMP inspection of this Site.
This Unit of Shilpa Medicare 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 Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
