Alembic Pharmaceuticals Ltd on Thursday, May 9, said it received approvals from the United States Food and Drug Administration (USFDA) from April 1 to May 8, to launch five drugs.
The USFDA clearances include both tentative and final approvals, the drug maker said in a stock exchange filing.
During the period, Alembic Pharma obtained final approval for Diazepam Syringe, which is used to treat anxiety disorders and short-term relief of anxiety symptoms.
The company also got the final nod for Tretinoin Cream USP, 0.1% and Clindamycin 1% Gel. Both of the products are indicated for the treatment of skin diseases.
The company received tentative approval for Selexipag tablets, which are used in the treatment of pulmonary arterial hypertension (PAH), as well as Binimetinib tablet, which is recommended for the treatment of unresectable or metastatic melanoma.
With these, the company now has a total of 201 ANDA approvals from the USFDA, consisting of 173 final approvals and 28 tentative approvals.
Alembic Pharmaceuticals is poised to announce its results for the fourth quarter of FY24 on Thursday, May 9.
Earlier this week, Alembic Pharmaceuticals said that it obtained an establishment inspection report (EIR) from the USFDA for its oncology facility in Gujarat.
The inspection took place at the facility from February 28 to March 8. Additionally, the company notified the stock exchanges that EIRs have been secured for all of its facilities inspected by the USFDA.
Shares of Alembic Pharma were trading 0.68% lower at ₹996.95 apiece at 11 am.
Also Read: ICICI Lombard Block Deal Exclusive: ICICI Bank buyer, while Bharti Enterprises sells
The USFDA clearances include both tentative and final approvals, the drug maker said in a stock exchange filing.
During the period, Alembic Pharma obtained final approval for Diazepam Syringe, which is used to treat anxiety disorders and short-term relief of anxiety symptoms.
The company also got the final nod for Tretinoin Cream USP, 0.1% and Clindamycin 1% Gel. Both of the products are indicated for the treatment of skin diseases.
The company received tentative approval for Selexipag tablets, which are used in the treatment of pulmonary arterial hypertension (PAH), as well as Binimetinib tablet, which is recommended for the treatment of unresectable or metastatic melanoma.
With these, the company now has a total of 201 ANDA approvals from the USFDA, consisting of 173 final approvals and 28 tentative approvals.
Alembic Pharmaceuticals is poised to announce its results for the fourth quarter of FY24 on Thursday, May 9.
Earlier this week, Alembic Pharmaceuticals said that it obtained an establishment inspection report (EIR) from the USFDA for its oncology facility in Gujarat.
The inspection took place at the facility from February 28 to March 8. Additionally, the company notified the stock exchanges that EIRs have been secured for all of its facilities inspected by the USFDA.
Shares of Alembic Pharma were trading 0.68% lower at ₹996.95 apiece at 11 am.
Also Read: ICICI Lombard Block Deal Exclusive: ICICI Bank buyer, while Bharti Enterprises sells
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