Drug Approval | October 30, 2025
Granules India’s facility secures FDA EIR with 'VAI’
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The facility has been classified as Voluntary Action Indicated
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
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