Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume

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