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About 440 results for "usfda"

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Money Control, 23 hours ago
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Money Control, 4 days ago
Money Control, 6 days ago
Money Control, 6 days ago
Money Control, 1 week ago
Business Standard, 18 hours ago
Money Control, 1 week ago
Money Control, 2 weeks ago
Sify

Sun Pharma in pink of health after USFDA clears facility post inspection

Sun Pharmaceutical Industries gained 2.4% to Rs 538.40 at 10:00 IST on BSE after the company said that the US drug regulator cleared its Dadra facility based on responses to its inspection conducted in April this year.
 Business Standard4 days ago Dr Reddy's in pink of health after USFDA clears facility  Business Standard3 weeks ago Dr Reddy's extends gains after USFDA clears Hyderabad facility after audit  Business Standard3 weeks ago Orchid Pharma recovers after USFDA gives green signal to facility  Business Standard3 weeks ago
Business Standard

Biocon up 5% as USFDA issues CRL for proposed Biosimilar

The stock moved higher by 5.5% to Rs 363 on BSE in noon deal after the company said the USFDA has issued a Complete Response Letter (CRL) for proposed Biosimilar Pegfilgrastim. Last Updated at October 10, 2017 14:23 IST
 Business Standard6 days ago Biocon intimates of CRL issued by USFDA  Business Standard6 days ago USFDA issues CRL for proposed biosimilar Pegfilgrastim: Biocon  Business Standard6 days ago

Shilpa Medicare gets EIR from USFDA for Jadcherla facility

Shilpa Medicare today said the USFDA has issued an Establishment Inspection Report (EIR) for its Jadcherla facility in Telangana.The US health regulator has issued an EIR for the company's generic pharmaceutical manufacturing facility at Jadcherla, which was ...
 Business Standard1 week ago Shilpa Medicare receives EIR report for facility in Jadcherla in Telangana  Business Standard1 week ago Shilpa Medicare concludes USFDA inspection at Telangana facility  Myiris2 months ago
Money Control

Granules India gains 4% on EIR from USFDA for Vizag facility

The said facility was inspected by USFDA in December 2016 and there were seven observations during the inspection.
 Money Control1 week ago Granules India rises after Vizag facility gets EIR from USFDA  Business Standard1 week ago Granules India jumps after USFDA clears facility  Business Standard2 months ago USFDA issues EIR for Granules India's Gagillapur plant  Business Standard2 months ago
Money Control

Natco partner's multiple sclerosis injection gets USFDA nod

The US Food and Drug Administration has granted approval to drug major Natco Pharma's marketing partner Mylan's Glatiramer Acetate injection used for treatment of relapsing forms of multiple sclerosis (MS).The approval is granted to the drug in strengths of ...
 Business Standard1 week ago Natco Pharma zooms 20% as partner's injection gets USFDA nod  Business Standard1 week ago Natco Pharma locked at 20% upper circuit as partner Mylan gets USFDA nod for multiple sclerosis drug  Money Control1 week ago
Money Control

Biocon gets CRL from USFDA for anti-cancer drug

Biotechnology firm Biocon today said the US health regulator has issued complete response letter (CRL) for proposed biosimilar Pegfilgrastim, indicated for use in the treatment of cancer.The company, however said it does not expect this CRL to impact the ...
 Business Standard6 days ago Biocon receives CRL from USFDA for anti-cancer drug  Business Standard6 days ago
Sify

Natco Pharma up 20% as Mylan gets USFDA nod for generic Glatiramer Acetate

The stock up 20% to Rs 954 on BSE after the company said its marketing partner Mylan receives final approval of generic Glatiramer Acetate, for both 20 mg/mL and 40 mg/mL versions.
 Business Standard1 week ago Natco Pharma hits the roof after getting USFDA nod for Copaxone  Sify1 week ago Natco Pharma hits roof after USFDA approval for generic  Business Standard1 week ago Generic Drug Approvals Hit The Roof  Equitymaster.com6 days ago
Money Control

Biocon advances as Vishakhapatnam unit clears USFDA inspection

Biocon rose 2.37% to Rs 365.50 at 09:17 IST on BSE after the company announced that the USFDA has completed its Vishakhapatnam unit's inspection with no observations.
 Business Standard3 weeks ago Laurus Labs gains 2% on EIR from USFDA  Money Control4 weeks ago Laurus Labs in pink of health on completion of USFDA inspection  Business Standard1 month ago Laurus Labs rises 3% on completion of USFDA inspection  Money Control1 month ago
Money Control

Alkem Laboratories slips 3% on USFDA observations for Baddi facility

The company has received the inspection report from USFDA which contains two 483 observations.
 Money Control4 weeks ago Alkem Laboratories drops after receiving observations from USFDA for facility  Business Standard4 weeks ago Alkem Laboratories intimates of USFDA inspection at Baddi facility  Myiris4 weeks ago Divis Laboratories intimates of USFDA inspection of Unit-2  Business Standard3 weeks ago
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