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Expectations and predictions for 2022
Opinion | December 28, 2021

Expectations and predictions for 2022

In India, healthcare has become one of the fastest-growing economic sectors which comprise hospitals, pharma companies, medical equipment and devices, medical tourism, health insurance, clinical trials etc


Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


Lupin receives U.S. FDA approval for Sevelamer Carbonate
Drug Approval | December 27, 2021

Lupin receives U.S. FDA approval for Sevelamer Carbonate

This product will be manufactured at Lupin's Goa facility in India


NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


Sun gets US FDA approval for generic amphotericin B injection
Drug Approval | December 16, 2021

Sun gets US FDA approval for generic amphotericin B injection

It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity


Alembic receives tentative USFDA approval for Selexipag tablets
Drug Approval | December 09, 2021

Alembic receives tentative USFDA approval for Selexipag tablets

The tablets are indicated for the treatment of pulmonary arterial hypertension


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)


U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
Drug Approval | November 23, 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies