Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days

Piramal Pharma completes USFDA inspection of Aurora facility with Zero Form-483 observations

Aurolife Pharma gets 11 observations from USFDA for Raleigh plant

The company does not expect this development to have any material impact on the current business operations

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

The company will provide the necessary response on these observations to USFDA within stipulated 15 days

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.

Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection

Cenexi is committed to working closely with the ANSM to address the observations