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Results For "SEZ"

124 News Found

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


USFDA completes regulatory inspection of Natco's Vizag formulation facility
News | February 06, 2023

USFDA completes regulatory inspection of Natco's Vizag formulation facility

At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure


Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

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


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Briefs: Piramal Enterprises and Shilpa Medicare
News | December 02, 2022

Briefs: Piramal Enterprises and Shilpa Medicare

Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval


Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)


Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Drug Approval | November 09, 2022

Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

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


Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data