Shilpa Medicare shares zoom as USFDA concludes inspection

USFDA has concluded inspection at Shilpa Medicare’s facility. The shares gained over 4 per cent on Monday morning.

US Food and Drug Administration (USFDA) had conducted inspection at Shilpa Medicare’s Finished Dosage Formulation Facility (Sterile and Non-sterile Dosage Forms) located at S-20 to S-26, Pharmaceutical Formulations SEZ, APIIC, Jadcherla in the state of Telangana from August 29, 2019 to September 6, 2019.The inspection concluded with two observations. There were no repeat observations or Data Integrity (DI) related observations.

The company has mentioned that it is addressing these observations and will respond to the USFDA at the earliest.

In July, Shilpa Medicare had received Form 483 with 5 observations from USFDA, with no repeat observations and any data integrity observations at its Active Pharmaceutical Ingredients (API) site at Raichur, Karnataka.

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.

The shares of Shipla Medicare on Monday opened at Rs. 260.50 against Friday’s close of Rs. 259.65. At 09:40AM, it was trading at Rs. 275, gaining 4.08 per cent from its previous close. The stock hit an intraday high of Rs. 275 and intraday low was Rs. 260. Its 52-week high was Rs. 546.95 and 52-week low was Rs. 190.80 per share on the BSE.