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

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

Lincoln Pharmaceuticals posts Q1 FY24 standalone net profit at Rs. 19.01 Cr

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

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

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines

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.