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The inspection was conducted from 8th to 10th March 2023. The USFDA has issued 2 minor observations which are related to improvements in existing procedures and are addressable.
Shilpa Medicare said that it will be submitting the responses to USFDA observations within stipulated timeline and will work towards implementing the corrective actions to address the observations.
This is the second USFDA inspection on the site. The initial inspection was done in April last year, for which the GMP clearance (EIR) was issued in July 2022.
The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. The facility is involved in the testing of US/EU & other markets commercial batches.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.
The company reported a consolidated net loss of 6.62 crore in Q3 FY23 as against a net profit of Rs 9.57 crore posted in Q3 FY22. Net sales declined 3.6% year on year to Rs 262.50 crore during the quarter.
The scrip declined 4.34% to settle at Rs 268.85 on Friday, 10 March 2023.
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