Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated

USFDA inspection at Piramal Pharma’s Bethlehem facility

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483

Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations

Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million

The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year

USFDA delegation visits Amneal Pharmaceutical facility in Matoda

Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.

USFDA completes PAD E inspection of Marksans' Goa facility

The inspection was conducted at its Goa, Vema manufacturing facility