News about "United States Food and Drug Administration (US FDA"

Lupin Receives EIR from US FDA for its Pithampur Unit-3 Facility

Lupin Receives EIR from US FDA for its Pithampur Unit-3 Facility

Following an inspection in July 2025, Lupin received the USFDA’s Establishment Inspection Report (EIR) for its Pithampur Unit-3 facility.

United States Food And Drug Administration (US FDA | 06/11/2025 | By Dineshwori

Lupin Secures US FDA Approval for Lenalidomide Capsules

Lupin Secures US FDA Approval for Lenalidomide Capsules

The approved Lenalidomide Capsules, bioequivalent to Revlimid by Bristol-Myers Squibb, will be produced at Lupin’s Pithampur site in India.

United States Food And Drug Administration (US FDA | 17/09/2025 | By Dineshwori 163

Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection

Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection

The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.

United States Food And Drug Administration (US FDA | 06/09/2025 | By Dineshwori 186


 

 

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