Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product

Lupin receives approval from USFDA for Glycopyrrolate Injection USP

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products

Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection

The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities

Lupin receives tentative approval from USFDA for DETAF tablets

DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA

Lupin receives tentative approval from USFDA for Dolutegravir and Rilpivirine Tablets

Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)

USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions

The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22

Lupin receives approval from USFDA for Prasugrel Tablets, USP