Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US

Unichem receives ANDA approval for Prasugrel Tablets

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India

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

Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials

Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).

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

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.