Shilpa Medicare has informed that Shilpa Medicare, Unit VI, Dabaspet, Bengaluru, India was inspected by USFDA on 24, 25 and 28, 29, 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. All observations 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.
The above information is a part of company’s filings submitted to BSE.
