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.
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals
From material selection to cooling tower management, every small decision affects long-term equipment reliability
The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta
The Cranbury facility represents a strategic advancement of the company's operations in the Unted States
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