-
Torrent Pharma recalls 27,000 bottles of BP lowering medicine in the US
ExpressPharma
December 28, 2021
Torrent Pharma is recalling more than 27,000 bottles of its generic drug, used in lowering high blood pressure, in the US market.
-
Dr. Reddy's Laboratories Announces the Launch of Venlafaxine ER Tablets in the U.S. Market
AmericanPharmaceuticalReview
December 13, 2021
Dr. Reddy’s Laboratories Ltd. announced the launch of Venlafaxine ER Tablets which is therapeutically equivalent to Venlafaxine Extended-Release Tablets, 150 mg and 225 mg, of Osmotica Pharmaceutical US LLC approved by the U.S. Food and Drug ...
-
Zydus receives tentative nod from USFDA for Empagliflozin Tablets
expresspharma
April 13, 2020
The medication is used to improve blood sugar control in adults with Type 2 diabetes mellitus, along with diet and exercise.
-
Granules India gets USFDA approval for Butalbital, Acetaminophen, Caffeine capsules
expresspharma
April 10, 2020
Granules India on said its foreign subsidiary has received approval from the US health regulator for Butalbital, Acetaminophen and Caffeine Capsules used to treat tension headaches.
-
Alembic Pharma receives four observations from USFDA for Panelav facility
expresspharma
March 17, 2020
"The US Food and Drug Administration (USFDA) had conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav from 9-13 March, 2020," the drug firm said in a filing to the BSE.
-
Seattle Genetics, Astellas gets USFDA priority review for Enfortumab Vedotin
biospectrumasia
September 18, 2019
The filing is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2019.
-
Lupin gets EIR from USFDA for Aurangabad facility
expresspharma
August 05, 2019
Drug firm Lupin said that it has received an Establishment Inspection Report (EIR) from the US health regulator for its Aurangabad facility in Maharashtra.
-
Alembic Pharma gets tentative nod from USFDA for glycemic control drug
expresspharma
July 30, 2019
Drug firm Alembic Pharmaceuticals said it has received tentative approval from the US health regulator for Dapagliflozin Tablets, a medication that helps to reduce blood glucose levels.
-
USFDA clears Indoco’s Goa Plant II and III
expresspharma
July 30, 2019
Indoco Remedies has announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for their sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa.
-
USFDA inspection at Chennai facility ends with zero observations: Natco Pharma
expresspharma
July 18, 2019
Natco Pharma has said the US health regulator has completed the inspection of its Chennai facility, and it ended with zero observations.