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FDA fast-tracks first drug nod under new national priority voucher program
News | December 12, 2025

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


Apitoria Pharma receives 3 observations from USFDA for Unit-V
Drug Approval | December 12, 2025

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines


Teva files FDA application for once-monthly schizophrenia injection
Drug Approval | December 11, 2025

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time


Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
interviews | December 10, 2025

Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group

India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines


Fermenta Biotech to invest Rs. 110 crore for Dahej plant expansion
Biotech | December 10, 2025

Fermenta Biotech to invest Rs. 110 crore for Dahej plant expansion

This strategic investment aims to bolster the company's position as a global leader in Vitamin D3 manufacturing


Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags
News | December 09, 2025

Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older


Bayer advances fight against rare kidney disease with new experimental drug
R&D | December 07, 2025

Bayer advances fight against rare kidney disease with new experimental drug

Alport Syndrome is caused by genetic mutations affecting type IV collagen in the kidneys, ears, and eyes


Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment
Drug Approval | December 06, 2025

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment

The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation


Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US