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About 161 results for "us fda"

US FDA expediting of generic approvals a mixed bag for India drug makers
Money Control

US FDA expediting of generic approvals a mixed bag for India d...

The US drug regulator has cleared record number of abbreviated new drug applications (ANDAs) in 2017, as it aims to expand competition in generic drugs and there by reduce healthcare costs for US citizens. Money Control, 2 days ago
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38 images for us fda

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Money Control

Alkem Laboratories gets EIR for Baddi facility

This is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Company#39;s manufacturing facility located at Baddi, India which was inspected from 11th September, 2017 to 15th September, 2017.
 Money Control5 days ago Alkem gets EIR report from USFDA for Baddi facility  Business Standard5 days ago Biocon facility gets inspection closure report from USFDA  Business Standard1 month ago
Business Standard

Pharma corner: Fresenius Kabi gets US FDA warning for Baddi plant

US FDA asked the drug firm to provide plans and procedures to ensure that future sterility failure investigations included a more thorough review of long-term trends Press Trust of India | New Delhi Last Updated at January 4, 2018 00:45 IST US health ...
 Business Standard1 week ago

BUZZ-India's Sun Pharma hits 5-month high after U.S. FDA accepts new drug application

** Shares of Sun Pharmaceutical Industries Ltdclimb as much as 6.4 pct to 576 rupees, highest since July 27 ** Co said U.S. FDA accepted a New Drug Application (NDA),filed by its unit, for OTX-101, a solution to treat dry eyedisease ** "Co is one of the few ...
 Sify2 weeks ago Sun Pharma spurts on USFDA nod for new drug application  Sify2 weeks ago Sun Pharma shares rally 7% after USFDA accepts new drug application for dry eye solution  Money Control2 weeks ago
Money Control

FDA approves Mylan's copy of Allergan's vaginal cream

(Reuters) - Mylan NV said the U.S. Food and Drug Administration had granted it the approval for a generic version of Allergan's Estrace cream for vaginal atrophy.
 Reuters2 weeks ago Dr Reddy#39;s Labs gains on US FDA nod for Sapropterin Dihydrochloride  Money Control2 weeks ago FDA approves La Jolla's low blood pressure drug  Reuters3 weeks ago Laurus Labs surges 5% on maiden USFDA approval for HIV drug  Money Control1 month ago
Business Standard

US FDA issues adverse observations on Glenmark plant

The firm makes dermatology products including ointment and contributes around 10% of its US sales Aneesh Phadnis | Mumbai Last Updated at November 29, 2017 01:08 IST The US Food and Drug Administration (US FDA) has found deficiencies in manufacturing ...
 Business Standard1 month ago Glenmark Pharma gets 7 US FDA observations for Baddi unit, to reply soon  Business Standard1 month ago USFDA issues 7 observations to Glenmark Pharma#39;s Baddi unit  Money Control1 month ago Glenmark Pharma shares gain 3% on USFDA approval for birth control pill  Money Control2 weeks ago
Sify

Biocon hits record high on US FDA approval for generic cancer drug Ogivri

Biocon Ltd jumps as much as 13.8 pct to hit a record high of 509.00 rupees. The biopharmaceutical company and its partner Mylan NV get U.S. FDA approval for Ogivri, biosimilar of Herceptin - used as a treatment for breast cancer. This is the first U.S./EU ...
 Sify1 month ago Zydus gets tentative US FDA nod to sell pregabalin for seizures, pain  Business Standard1 month ago US regulator audits Biocon drug facility in Bengaluru  Prokerala1 month ago Lupin dives to near 4-year lows on FDA warnings  Sify2 months ago

Sun Pharma rises 2% after Taro gets US FDA nod for antiacne drug

Clindamycin Phosphate Benzoyl Peroxide Gel is indicated for the treatment to moderate acne.
 Money Control3 weeks ago

This $850,000 Gene Therapy Injection Is the Most Expensive One-Time Dose Medicine Ever Made

A new and first-of-its-kind gene therapy treatment for inherited blindness, called Luxturna, was approved by the FDA last month. The groundbreaking medication, however, comes with the staggering cost of USD 850,000, making it one of the most expensive ...
 Oddity Central3 days ago First gene therapy for rare blindness gets US FDA nod  Business Standard3 weeks ago FDA approves Spark's gene therapy for rare form of blindness  Reuters3 weeks ago U.S. FDA approves Gilead cancer gene therapy; price set at $373,000  Reuters2 months ago

Wockhardt jumps 11% after company offers Waluj facility for US FDA inspection

Wockhardt jumped over 9 percent intraday on Thursday hitting a new 52-week high of Rs 882 per share after the company said that it will be offering its Waluj facility near Aurangabad, Maharashtra in early 2018 for US FDA inspection.
 Money Control3 weeks ago
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