Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 28

Results For "United-States-Food-and-Drug-Administration"

379 News Found

Zydus receives final approval from USFDA for Estradiol Transdermal System
Drug Approval | December 05, 2022

Zydus receives final approval from USFDA for Estradiol Transdermal System

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


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)


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
Drug Approval | November 29, 2022

Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India


Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


Aurobindo Pharma receives 10 observations for Unit IX
Drug Approval | November 21, 2022

Aurobindo Pharma receives 10 observations for Unit IX

The company had responded to the agency and carried out the required corrective actions.


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US


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 receives EIR with VAI from USFDA for Moraiya facility
Drug Approval | November 08, 2022

Zydus receives EIR with VAI from USFDA for Moraiya facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)