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About 199 results for "usfda"

Sun Pharma gains 3% on USFDA approval for psoriasis drug Ilumya
Money Control

Sun Pharma announces USFDA approval of ILUMYA drug

announced that the U.S. Food and Drug Administration (FDA) has approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMYAâ„¢ selectively ... Myiris, 9 hours ago
Sun Pharma gains on USFDA nod for psoriasis drug Ilumya Business Standard, 19 hours ago

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Money Control

Closing Bell: Sensex ends 74 pts higher but fails to hold 33K; Bharti Infratel up 5%

Cipla recovered from day#39;s low after the company clarified saying certain observations issued by the USFDA during product specific pre-approval inspection of Goa unit are procedural in nature.
 Money Control1 day ago Alembic Pharma gets 3 observations from USFDA for Gujarat plant  Business Standard1 day ago Alembic Pharma gains 3% after clarifies on USFDA observations  Money Control1 day ago Dr Reddy’s Laboratories declines 3% on Form 483 from USFDA  Money Control6 days ago

Alembic Pharm intimates of USFDA inspection of facility at Panelav

 Myiris1 day ago Alembic Pharmaceuticals intimates of USFDA inspection of facility at Panelav  Business Standard1 day ago
Business Standard

Lupin receives USFDA nod for generic Topicort topical spray

announced that it has received final approval for its Desoximetasone Topical Spray, 0.25%, 30 ml, 50 ml, and 100 ml from the United States Food and Drug Administration (FDA) to market a generic version of Taro Pharmaceuticals U.S.A Inc.'s Topicort Topical ...
 Myiris2 days ago Lupin rises 1% on USFDA approval for Desoximetasone topical spray  Money Control2 days ago Lupin receives FDA approval for generic Topicort Topical Spray, 0.25%.  Business Standard3 days ago Lupin gets USFDA nod for psoriasis treatment spray  Business Standard3 days ago
Business Standard

Shilpa Medicare gains 7% on EIR for Jadcherla formulations unit

The stock was 7% to Rs 488 on the BSE after the company received EIR from the USFDA for its formulation manufacturing facility in Telangana following the audit in November last year. SI Reporter | Mumbai Last Updated at March 19, 2018 10:06 IST Shilpa ...
 Business Standard3 days ago Shilpa Medicare update on USFDA inspection of Polepally formulations unit  Business Standard5 days ago Panacea Biotec receives EIR Report for its Oncology Parenteral Formulations manufacturing facility  Business Standard1 week ago Panacea Biotec gets EIR from USFDA for its Baddi facility  Business Standard1 week ago
Money Control

Cipla shares trim losses after company clarifies on USFDA observations for Goa unit

Cipla told CNBC-TV18 the Goa unit observations are procedural addressable in nature.
 Money Control2 days ago Cipla shares drop 7% on USFDA observations for Goa unit  Money Control2 days ago Cipla rebounds after clarification on USFDA observations for Goa unit  Business Standard2 days ago
Business Standard

Shilpa Medicare rises 7% on EIR from USFDA for Telangana facility

The said facility was inspected between November 11 and November 30, 2017.
 Money Control2 days ago Granules India rises 2% on EIR from USFDA  Money Control3 weeks ago Natco Pharma rallies 6% on zero observations for Mekaguda unit post USFDA inspection  Money Control1 month ago Natco Pharma announces completion of USFDA inspection of API facility near Hyderabad  Business Standard1 month ago
Money Control

Cipla gets USFDA observations for its Goa plant

The United States Food and Drug Administration (USFDA) had conducted a product specific pre-approval inspection at company#39;s Goa plant in January 2018, Cipla said in a BSE filing.
 Money Control2 days ago Indoco Remedies gets 8 USFDA observations for its Goa unit  Myiris1 month ago Lupin hopes to resolve warning letter on Goa and Indore plants by end of FY19  Money Control1 month ago USFDA issues warning letter to Fresenius Kabi for Baddi plant  Money Control2 months ago
Business Standard

USFDA approvals can unlock $1 bn biosimilar business for Biocon in the US

We have at least a five-year head start in biosimilars compared with other Indian drugmakers, says Mazumdar-Shaw Ari Altstedter | Bloomberg Last Updated at March 20, 2018 10:11 IST Biocon's facility. Photo: Company's website Biocon Ltd, the only Indian ...
 Business Standard2 days ago
Money Control

Strides Shasun gets USFDA approval for Efavirenz Tablets

According to IQVIA data, the US market for Efavirenz Tablets USP, 600 mg is approximately USD 115 Million and Strides is only the second generic company to get the approval for the product under the para IV route. The product will be manufactured at the ...
 Business Standard1 week ago Strides Shasun gains 1% on USFDA approval for Efavirenz Tablet  Money Control1 week ago Strides Shasun gets USFDA nod for HIV treatment drug  Money Control1 week ago Strides Shasun receives USFDA approval for Efavirenz tablets  Myiris1 week ago
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