Industry News

6 September 2024

Sun Pharma and Moebius Medical Announce Fast Track Designation Granted for MM-II for the Treatment of Osteoarthritis Knee Pain

Sun Pharma and Israel-based Moebius Medical Limited announced that the U.S. Food and Drug Administration has granted Fast Track designation to MM-II Large Liposomes of DPPC and DMPC for the treatment of osteoarthritis knee pain. Planning for confirmatory Phase 3 clinical trials for MM- II is underway.

22 August 2024

Indoco Remedies receives ANDA approval from USFDA for Lofexidine

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg with Competitive Generic Therapy designation, It is a generic equivalent of Lucemyra Tablets, 0.18 mg of USWM, LLC.

20 August 2024

Granules India Limited Receives ANDA approval for Glycopyrrolate Oral Solution

Granules India announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application for Glycopyrrolate Oral Solution 1mg/5mL filed by Granules Pharmaceuticals, Inc. , a wholly owned foreign subsidiary of the Company.

15 August 2024

Alembic Pharmaceuticals receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India.

1 August 2024

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific APAC, Latin America LATAM, Europe, and Middle East regions.

29 July 2024

Another Indian discovered medicine, deuruxolitinib gets FDA approval against baldness

Indian Pharma giant, Sun Pharma gets the U.S. Food and Drug Administration, FDA approval for LEQSELVI deuruxolitinib 8 mg tablets for the treatment of adults with severe alopecia areata.

19 July 2024

Zydus announces non-exclusive patent licensing agreement with Takeda for Vault Vonoprazan in India

Zydus Lifesciences Limited discovery-driven global lifesciences company has entered into a non-exclusive patent licensing agreement with Takeda Pharmaceutical Company to market the novel Potassium Competitive Acid Blocker P-CAB Vonoprazan in India.

26 June 2024

USDA approves Merck Animal Health’s NOBIVAC NXT Canine Flu H3N2

NOBIVAC NXT is a revolutionary, first-of-its-kind vaccine technology for companion animals that leverages RNA-particle technology, allowing for a precise immune response to protect against a wide range of viral and bacterial pathogens.

25 June 2024

EMA approves Biocon Biologics’ New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

Biocon Biologics Ltd , a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd, has received approval from the European Medicines Agency to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies mAbs drug substance facility at Bengaluru.

17 June 2024

Alembic Pharmaceuticals announces USFDA approval for Icatibant Injection

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Icatibant Injection

Search

Sun Pharma and Moebius Medical Announce Fast Track Designation Granted for MM-II for the Treatment of Osteoarthritis Knee Pain

RECOMMENDED POSTS

Subscribe with us

Jobs by Category