News | November 13, 2025
Lupin receives EIR from FDA for its Aurangabad facility
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 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 inspection was carried out between May 26, 2025 and May 31, 2025
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The company received one observation in the Form-483
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
Zydus receives EIR for the API manufacturing facility at Ankleshwar
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
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