Drug Approval | July 24, 2025
NATCO Pharma API unit in Mekaguda receives EIR from USFDA
The company received one observation in the Form-483
The company received one observation in the Form-483
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Zydus receives EIR for the API manufacturing facility at Ankleshwar
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
Biocon Biologics remains committed to global standards of quality and compliance
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
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