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

Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets

The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru

Briefs: Cipla and IOL Chemicals and Pharmaceuticals

Mesalazine is used to treat inflammatory bowel disease

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles

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

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets

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

Morepen Laboratories approves hiving off of medical devices business

DBT hosts webinar on Biomanufacturing for Climate Resilient Agriculture