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

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure