Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial

Briefs: Link Pharma Chem and Zydus

USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad

Granules India successfully completes Two US FDA Audits in a span of 2 weeks

The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.

Industry needs to establish a self-regulatory body to maintain the quality of the pharma products, says Dr Mandaviya

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

Briefs: Ipca Laboratories, Lupin and Zydus

The company has extended its full co-operation and support to the officials of the Income Tax Department