The inspection, performed from March 10 to March 14, 2025, concluded with none Type 483 being issued. This marks the second consecutive clear inspection on the web site.
“That is to tell you that the USA Meals and Medication Administration (USFDA) has performed an inspection at Unit-2 of Shilpa Pharma Lifesciences Restricted, positioned at Raichur, from March 10-14, 2025. The inspection was closed with ZERO observations.
That is the second consecutive ZERO 483 inspection from USFDA at this web site,” Shilpa Medicare stated in a regulatory submitting.
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Final week, Shilpa Medicare introduced that the USA Meals and Drug Administration (USFDA) has accomplished an inspection at Unit-1 of its wholly owned subsidiary, Shilpa Pharma Lifesciences Ltd, in Raichur.
“That is to tell you that the USA Meals and Medication Administration (USFDA) has performed an inspection at Unit-1 of Shilpa Pharma Lifesciences Restricted, positioned at Raichur, from March 3-7, 2025. On the conclusion of the inspection, we obtained 1 (one) remark in type 483, which is procedural in nature,” Shilpa Medicare stated in a regulatory submitting.
The inspection, performed from March 3 to March 7, 2025, resulted in a single procedural remark below Type 483. The corporate said that it’ll work carefully with the USFDA to handle the remark throughout the stipulated timeframe. “The corporate will carefully work with the company and stay dedicated to handle this remark comprehensively inside stipulated time,” it added.
Additionally Learn: Shilpa Medicare rallies as subsidiary will get European regulator’s nod for blood strain drug
On Thursday (March 13), shares of Shilpa Medicare Ltd ended at ₹628.20, down by ₹17.10, or 2.65%, on the BSE.
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