Indoco’s clinical research organisation ‘AnaCipher’ completes USFDA inspection

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics

GSK’s Penmenvy approved by FDA to help protect against MenABCWY

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030

Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby

Morepen Laboratories approves hiving off of medical devices business

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance

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.