December 11, 2018 10:55 AM IST
Strides Vivimed Pte Ltd, Singapore, a 50:50 joint venture with Vivimed Labs, has received approval from the United States Food & Drug Administration (US FDA) for Albendazole tablets in the strength of 200 mg, Strides Pharma Science said in a BSE filing.
December 10, 2018 02:59 PM IST
The company received the EIR for unit 3 of the facility. The site was inspected from June 12-16, 2017, Lupin said.
December 10, 2018 11:36 AM IST
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine Hydrochloride ophthalmic solution USP, 0.1 percent, Alembic Pharmaceuticals said in a filing to BSE.
December 05, 2018 11:55 AM IST
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Candesartan Cilexetil tablets USP in the strengths of 4 mg, 8 mg, and 16 mg, Alembic Pharmaceuticals said in a filing to BSE.
December 04, 2018 06:14 PM IST
The company has launched its Silodosin capsules in the strengths of 4 mg and 8 mg after receiving an approval from USFDA.
December 04, 2018 11:07 AM IST
The company's wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Glycopyrrolate tablets USP in the strengths of 1 mg and 2mg, Alembic Pharmaceuticals said in a BSE filing.
November 29, 2018 01:26 PM IST
The final approval from the United States Food and Drug Administration is to market Lansoprazole delayed release orally disintegrating tablets in the strengths of 15 mg and 30 mg.
November 27, 2018 02:49 PM IST
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Baclofen tablets in the strengths of 10 mg and 20 mg, Zydus Cadila said in a filing to BSE.
November 27, 2018 01:26 PM IST
The inspection, conducted by the United States Food and Drug Administration (USFDA) between August 27 and August 31, concluded with an inspectional observation, Lupin said in a statement.
November 27, 2018 11:50 AM IST
The company has got approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 7.5mg, 15mg, 22.5mg and 40mg, Alembic Pharmaceuticals said in a BSE filing.
November 27, 2018 11:40 AM IST
The US Food & Drug Administration has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc, subsidiary of Granules India Ltd.
November 22, 2018 03:53 PM IST
"The inspection concluded with the company receiving two minor observations, none of which are repeat in nature," Indoco Remedies said in a regulatory filing.
November 22, 2018 03:32 PM IST
The Ahmedabad-based group has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 10 mg, 20 mg, 40 mg and 80 mg, Zydus Cadila said in a statement.
November 16, 2018 01:50 PM IST
The company also said in the regulatory filing that it had received final approval from the United States Food and Drug Administration (USFDA) to market generic Fondaparinux Sodium injection.
November 16, 2018 10:55 AM IST
The company's abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (USFDA), Shilpa Medicare said in a BSE filing.
November 16, 2018 10:50 AM IST
Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, the company said in a BSE filing.
November 15, 2018 02:32 PM IST
The company has received an approval from the United States Food and Drug Administration (USFDA) to market Decitabine for Injection, 50 mg/vial, single-dose vial, Lupin said in a statement.
November 13, 2018 01:05 PM IST
The product approved by the United States Food and Drug Administration (USFDA) is a generic version of AstraZeneca Pharmaceuticals LP's Pulmicort Respules Inhalation Suspension, 0.5 mg/2 mL, Lupin said in a regulatory filing.
November 12, 2018 11:55 AM IST
Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram and 1 mg/gram, the company said in a BSE filing.
November 05, 2018 03:28 PM IST
The company has received approval from the United States Food and Drug Administration (USFDA) to market its Doxercalciferol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials, Lupin said in a statement.
October 31, 2018 01:52 PM IST
The company said it had submitted a detailed compliance report to the US Food and Drug Administration (USFDA) within the stipulated period in response to the Form 483 containing eight observations issued to it by the regulator.
October 29, 2018 12:40 PM IST
"Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations," the company said in a BSE filing.
October 29, 2018 11:33 AM IST
The company has received final nod from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Metoprolol ER tablets in the strengths of 50mg, 100mg and 200mg, Cipla said in a BSE filing.
October 26, 2018 01:27 PM IST
Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for the oil in the strength of 0.01 percent, the Mumbai-based company said in a statement.
October 23, 2018 02:38 PM IST
The company has received the final approval from the United States Food and Drug Administration (USFDA) to market Clobazam tablets in the strengths of 10 mg and 20 mg, in the American market, Zydus Cadila said in a statement.
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