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

Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)

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

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity

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

The company will address these observations within the stipulated timeline

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension

Piramal Pharma’s Ahmedabad facility completes USFDA PAI

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions

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

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

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India

Olverembatinib approved for commercialization in Macau China

Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program

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

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population

Alembic announces USFDA tentative approval for Bosutinib Tablets, 100 mg and 500 mg

Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer

Imfinzi also recommended for patients with mismatch repair deficient disease

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Jubilant Ingrevia receives EIR from USFDA for Unit-1 at Bharuch

This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative