Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration

Mankind Pharma signs agreement with Takeda to commercialize Vonoprazan in India

Vonoprazan is a potassium-competitive acid blocker (P-CAB) used for the treatment of acid-related disorders

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

The company will address these observations within the stipulated timeline

Piramal Pharma’s Ahmedabad facility completes USFDA PAI

Moderna and Mitsubishi Tanabe Pharma ink agreement to promote Moderna’s mRNA respiratory vaccine portfolio in Japan

The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed

Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection

The Unit has been issued GMP Certification from ANVISA-Brazil

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product

Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection

Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025