Cipla clarified that its supply partner Pharmathen received nine USFDA Form 483 observations during a November 2025 ...

Cipla said supplies of its key US drug Lanreotide will remain constrained after its manufacturing partner paused production ...

Despite repeated manufacturing infractions this year, Lupin has found itself on the receiving end of yet another FDA rebuke. Following an October FDA inspection, Lupin’s biotech manufacturing facility ...

* SHALL PUT TOGETHER DETAILED RESPONSE WITH ADEQUATE CORRECTIVE AND PREVENTIVE MEASURES TO ADDRESS US FDA OBSERVATIONS * ‍IN RESPONSE TO FORM 483 BY FDA AT CO'S ST LOUIS FACILITY, CO HAS SUBMITTED ...

The road to certification for Biocon’s insulin facility in Malaysia was long, winding and full of potholes. Now comes a detour. The FDA has slapped the factory with Form 483, citing six observations ...

Dr Reddy's Laboratories informed the stock exchanges on December 12, 2025, about the conclusion of the inspection.

Cipla had earlier received final USFDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths.

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency ...

GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a two-day inspection by the U.S. Food and Drug Administration (FDA). The inspection ...

The MarketWatch News Department was not involved in the creation of this content. GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a ...