Regulatory | 28 January 2023
USFDA provides exception to Glenmark's Baddi facility
The company will engage with the agency to resolve the import alert at the earliest.
The company will engage with the agency to resolve the import alert at the earliest.
Granules now have a total of 53 ANDA approvals from USFDA
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
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
The company has been issued ‘Form 483’ with two observations
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
The company will respond to these observations within the stipulated time period.
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022
Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.
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