USFDA inspection: Zydus Lifesciences and Gland Pharma

The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam

USFDA provides exception to Glenmark's Baddi facility

The company will engage with the agency to resolve the import alert at the earliest.

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA

USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa

USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.

Astellas announces hold lifted by FDA on Fortis clinical trial of AT845

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions

USFDA completes inspection at APL HealthCare

The company has been issued ‘Form 483’ with two observations

Stelis Biopharma’s flagship facility receives EIR from USFDA

The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes

Lupin receives tentative approval from USFDA for Dolutegravir and Rilpivirine Tablets

Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)

USFDA inspections gather pace; Indian pharma companies equipped to handle disruptions

The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22

USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India

Granules India’s Gagillapur facility completes USFDA inspection

The company will respond to these observations within the stipulated time period.

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults

USFDA inspects Piramal Pharma Lexington facility

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.

Zydus receives final approval from the USFDA for Febuxostat Tablets

Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).

Lupin receives approval from USFDA for Prasugrel Tablets, USP

Lupin receives approval from USFDA for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022