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465 News Found

Lupin receives EIR from FDA for its Aurangabad facility
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.


Lupin Bioresearch Center receives zero observations from USFDA
Drug Approval | November 08, 2025

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations


Senores Pharma forms new subsidiary in US
News | November 06, 2025

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals


Effective corrosion management demands a holistic approach: Experts
News | November 04, 2025

Effective corrosion management demands a holistic approach: Experts

From material selection to cooling tower management, every small decision affects long-term equipment reliability


FDA issues warning letter to Philips over manufacturing and quality system deficiencies
Medical Device | October 31, 2025

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

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


Granules India’s facility secures FDA EIR with 'VAI’
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


ACG to invest $200 million in US hard-shell capsule manufacturing
News | October 22, 2025

ACG to invest $200 million in US hard-shell capsule manufacturing

The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta


Biocon gets 1 USFDA observation for Cranbury site
Drug Approval | October 14, 2025

Biocon gets 1 USFDA observation for Cranbury site

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States