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Tag: usfda

You Searched For "usfda"
Wockhardt gets USFDA QIDP designation for WCK 6777

Wockhardt gets USFDA QIDP designation for WCK 6777

Ruchika Sharma22 April 2020 12:42 PM IST
New Delhi: Drug firm WockhardtNSE 0.09 % on Monday said it has received Qualified Infectious Disease Product (QIDP) designation from the US health...
Shilpa Medicare gets USFDA EIR for Raichur API Unit

Shilpa Medicare gets USFDA EIR for Raichur API Unit

Ruchika Sharma21 April 2020 12:07 PM IST
Raichur: Shilpa Medicare Limited has announced the receipt of Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA)...
Alembic Pharma gets USFDA Tentative nod for Alcaftadine Ophthalmic Solution

Alembic Pharma gets USFDA Tentative nod for Alcaftadine Ophthalmic Solution

Ruchika Sharma21 April 2020 11:08 AM IST
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for...
Strides gets USFDA nod for Flucytosine Capsules

Strides gets USFDA nod for Flucytosine Capsules

Ruchika Sharma20 April 2020 2:46 PM IST
Bangalore: Strides Pharma Science Limited today announced that its step‐down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore,...
Novartis gets USFDA nod to start randomized trial of malaria drug hydroxychloroquine against COVID-19

Novartis gets USFDA nod to start randomized trial of malaria drug hydroxychloroquine against COVID-19

Ruchika Sharma20 April 2020 2:34 PM IST
Zurich: Novartis has won the go-ahead from the U.S. Food and Drug Administration to conduct a randomized trial of malaria drug hydroxychloroquine...
Zydus gets USFDA final nod for Baclofen Tablets

Zydus gets USFDA final nod for Baclofen Tablets

Ruchika Sharma20 April 2020 10:46 AM IST
Ahmedabad: Zydus Cadila has received final approval from the USFDA to market Baclofen Tablets, 5 mg. Baclofen is used to treat muscle spasms caused by...
FDA approves tucatinib for treatment of advanced HER2-positive breast cancer

FDA approves tucatinib for treatment of advanced HER2-positive breast cancer

Dr. Kamal Kant Kohli19 April 2020 7:00 PM IST
The US Food and Drug Administration has approved the oral therapy tucatinib for the treatment of advanced HER2-positive breast cancer including cases...
Zydus gets USFDA final approval for Erlotinib Tablets

Zydus gets USFDA final approval for Erlotinib Tablets

Ruchika Sharma18 April 2020 10:54 AM IST
Ahmedabad: Zydus Cadila has received final approval from the USFDA to market Erlotinib Tablets (US RLD: Tarceva® Tablets), in the strengths of 25 mg,...
Biocon Biologics gets USFDA EIR for Two Manufacturing Facilities

Biocon Biologics gets USFDA EIR for Two Manufacturing Facilities

Ruchika Sharma17 April 2020 12:18 PM IST
Bengaluru: Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., said on Thursday it has received the Establishment Inspection Report (EIR)...
Zydus gets tentative USFDA nod for Macitentan Tablets

Zydus gets tentative USFDA nod for Macitentan Tablets

Ruchika Sharma16 April 2020 3:01 PM IST
Ahmedabad: Zydus Worldwide DMCC, a wholly-owned subsidiary of Cadila Healthcare Limited, has received tentative approval from the USFDA to market...
Lupin gets USFDA EIR for Mandideep Unit II Facility

Lupin gets USFDA EIR for Mandideep Unit II Facility

Ruchika Sharma16 April 2020 11:38 AM IST
Mumbai: Lupin Limited has announced the receipt of the Establishment Inspection Report (EIR) after the closure of the U.S. FDA inspection of its...
Daiichi-Ranbaxy row: HC allows the sale of Singh brothers firms to repay the Rs 3,500 crore arbitration award

Daiichi-Ranbaxy row: HC allows the sale of Singh brothers' firms to repay the Rs 3,500 crore arbitration award

Medical Dialogues Bureau24 Feb 2020 5:34 PM IST
New Delhi: The Delhi High Court today allowed the sale of unencumbered shares of the firms of former promoters of India's Ranbaxy Laboratories Ltd in...
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