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.
June 08, 2018 11:57 AM IST
"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Omeprazole Delayed-Release tablets OTC, 20mg. The product will be launched in June 2018," Aurobindo Pharma said in a BSE filing.
June 06, 2018 12:15 PM IST
"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1.5 mg/30 mcg) and Hailey Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets, 1.5 mg/30 mcg)," the company said in a BSE filing.
June 06, 2018 11:27 AM IST
"The US Food and Drug Administration (USFDA) inspected the manufacturing facility of our wholly-owned subsidiary, Alidac Pharmaceuticals Ltd located at SEZ, Ahmedabad from May 28 to June 5, 2018. At the end of the inspection, no observation (483) is issued," the company said in a BSE filing.
June 05, 2018 01:51 PM IST
The inspection was conducted by United States Food and Drug Administration (USFDA) in April 2018, Unichem Laboratories said in a filing to BSE.
May 28, 2018 11:12 AM IST
Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin Ointment USP, 100,000 units per gram, the company said in a BSE filing.
May 22, 2018 10:16 AM IST
"The company has submitted a new drug application (NDA) to the US Food & Drug Administration (USFDA) for... respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid," Glenmark Pharmaceuticals said in a BSE filing.
May 15, 2018 04:05 PM IST
The approval granted by the US Food and Drug Administration (USFDA) to the company's wholly-owned arm Jubilant Pharma Ltd, is for multiple strengths of Niacin extended-release tablets of 500 mg, 750 mg, and 1,000 mg, the company said in a statement.
May 14, 2018 12:11 PM IST
"The company's API manufacturing facility at Panoli, Gujarat has successfully passed periodical inspection by US Food and Drug Administration (USFDA) with two minor procedural observations," J B Chemicals and Pharmaceuticals said in a BSE filing.
May 14, 2018 10:31 AM IST
In a BSE filing, Lupin "announced successful completion of an inspection carried out by the United States Food and Drug Administration (USFDA) at its Nagpur facility. The inspection concluded without any observations".
May 07, 2018 04:59 PM IST
The company's product is the generic version of Novartis Pharmaceuticals Corp's Diovanb tablets and is indicated for lowering the blood pressure.
May 07, 2018 03:16 PM IST
The facility has undergone renewal inspection from February 5-18 by the United States Food and Drug Administration (USFDA), Suven Life Sciences said in a filing to BSE.
May 05, 2018 06:12 PM IST
The company has received approval from the United States Food and Drug Administration (US FDA) to market its product in the U.S. market, Zydus Cadila said in a statement.
May 02, 2018 10:31 PM IST
The USFDA has completed pre-approval inspection of the sterile drug product manufacturing facility in Bengaluru this week and issued a Form 483 with 7 observations, the filing said.
April 20, 2018 06:26 PM IST
The company's formulation manufacturing facility at Ghaziabad was inspected by the United States Food and Drug Administration (USFDA) from April 16, 2018 to April 20, 2018, Unichem Laboratories said in a BSE filing.
April 19, 2018 02:05 PM IST
The drug will be produced at the group's topical manufacturing facility at Ahmedabad, it said.
April 16, 2018 09:05 PM IST
"The United States Food and Drug Administration (USFDA) conducted a routine current Good Manufacturing Practices (cGMP) audit at its Indore formulations facility from April 2, 2018 till April 13, 2018," Cipla said in a BSE filing.
April 10, 2018 05:52 PM IST
The company had earlier said in a regulatory filing that audit of its active pharmaceutical ingredient (API) Cuernavaca plant in Mexico by the United States Food and Drug Administration (USFDA) was completed with zero observations.
March 27, 2018 03:56 PM IST
Lupin's product is a generic version of Galderma Laboratories LP's Clobex, which is indicated for treatment of moderate to severe plaque psoriasis.
March 27, 2018 03:15 PM IST
Glenmark Pharmaceuticals Inc, USA has received final approval by the United States Food & Drug Administration (USFDA) for Clobetasol Propionate spray 0.05 per cent, the company said in a statement.
March 20, 2018 08:48 PM IST
The United States Food and Drug Administration (USFDA) had conducted a product specific pre-approval inspection at company's Goa plant in January 2018, Cipla said in a BSE filing.
March 20, 2018 10:12 AM IST
Cipla told CNBC-TV18 the Goa unit observations are procedural & addressable in nature.
March 16, 2018 03:34 PM IST
"The audit of our API Hyderabad plant 1 at Jinnaram Mandal, Medak district, Telangana, by the USFDA has been completed today. We have been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time," Dr Reddy's said in a regulatory filing.
