September 24, 2018 01:48 PM IST
The week-long audit concluded without any observations and no Form 483 was issued, it added.
September 17, 2018 02:30 PM IST
According to IQVIA, Desvenlafaxine extended-release tablets has a market size of around $13.3 million for twelve months ending December 2017.
September 17, 2018 11:30 AM IST
"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Estradiol Vaginal Inserts USP, 10 mcg," the company said in a regulatory filing Monday.
September 12, 2018 05:27 PM IST
Dr Reddy's Neostigmine Methylsulfate injection, USP is available in strengths of 5 mg/10 ml and 10 mg/10 ml in multi-dose vials.
September 11, 2018 01:05 PM IST
The company has received tentative approval from the United States Food and Drug Administration (USFDA) for Sitagliptin tablets in strengths of 25 mg, 50 mg, and 100 mg, Zydus Cadila said in a BSE filing.
September 07, 2018 11:55 AM IST
"This was a scheduled inspection and at the end of the inspection, there were ZERO 483s," it added.
September 05, 2018 11:57 AM IST
Potassium Chloride extended-release tablet is a generic version of Klor-Con extended-release tablet of Upsher-Smith and Strides is the first Indian generic company to receive this approval.
September 05, 2018 11:42 AM IST
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Acyclovir Sodium Injection, 500 mg/10 mL and 1,000 mg/20mL single-dosevials, Cadila Healthcare said in a BSE filing.
September 03, 2018 12:05 PM IST
The tablets are being recalled on account of "Incorrect/Undeclared excipient: There is a potential an incorrect grade of excipient was used during manufacturing," it added.
August 30, 2018 02:52 PM IST
"Both the drugs will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad," it added.
August 29, 2018 08:38 PM IST
The company has received approval from United States Food and Drug Administration (USFDA) for Metformin hydrochloride tablets USP in the strengths of 500 mg, 850 mg and 1,000 mg, Laurus Labs said in a BSE filing.
August 29, 2018 01:10 PM IST
United States Food and Drug Administration (USFDA) conducted the inspection from August 20-28. Liva is a 100 percent subsidiary of Cadila Healthcare.
August 24, 2018 03:22 PM IST
The plant was inspected by the United States Food and Drug Administration (USFDA) in May 2018, Lupin said in a filing to BSE.
August 23, 2018 03:05 PM IST
The EIR from the United States Food and Drug Administration (USFDA) indicates closure of the audit of the plant, Dr Reddy's Labs said in a BSE filing.
August 16, 2018 04:30 PM IST
In the letter, the USFDA said inspectors during November 6-17, 2017, had found significant deviations from standard manufacturing practices at Apotex Research.
August 06, 2018 06:00 PM IST
The Roha facility was inspected by the United States Food and Drug Administration (USFDA) from July 30, 2018 to August 03, 2018, Unichem Laboratories said in a filing to the BSE.
August 01, 2018 11:44 AM IST
The company has received final approval from the US Food & Drug Administration (USFDA) for the drug, Zydus Cadila said in a statement.
July 30, 2018 02:22 PM IST
The company said in a statement that it has received nod from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg.
July 11, 2018 01:03 PM IST
Quoting IMS Health data, Dr Reddy's Laboratories the Plaquenil brand and generic had US sales of approximately USD 215 million for the most recent twelve months ending in May 2018.
July 09, 2018 09:10 PM IST
The drug is indicated for the treatment of malaria and acute and chronic rheumatoid arthritis in adults.
June 30, 2018 04:35 PM IST
Zydus Cadila today said it has received USFDA approval to market Triamterene and Hydrochlorothiazide tablets, indicated to treat high blood pressure. The approval has been granted for the tablets in strengths of 37.5 mg/25 mg and 75 mg/50 mg.
June 28, 2018 04:19 PM IST
In an earlier filing to the bourses on March 9, the drug firm had said it had received five observations from the US Food and Drug Administration (USFDA) for its API Hyderabad plant 3 at Medak district.
June 14, 2018 11:32 AM IST
The company has received final approval from the United States Food and Drug Administration (USFDA) for its product which is a generic version of Hospira Inc's Isuprel injection, Cipla said in a statement.
June 11, 2018 11:27 AM IST
"The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bupropion Hydrochloride tablets," Alembic Pharmaceuticals said in a BSE filing.
June 08, 2018 08:15 PM IST
In February, the USFDA had issued three observations after inspecting the facility. The company had said it was preparing the response to the observations.
Copyright © e-Eighteen.com Ltd All rights resderved. Reproduction of news articles, photos, videos or any other content in whole or in part in any form or medium without express writtern permission of moneycontrol.com is prohibited.
