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About 268 results for "us fda"

FDA approves Radius Health's osteoporosis drug Tymlos
Reuters

FDA approves Radius Health's osteoporosis drug Tymlos

The U.S. Food and Drug Administration on Friday approved Radius Health Inc's drug to treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies. The drug, Tymlos, is given by injection and was shown in ... Reuters, 18 hours ago

630 images for us fda

Business Standard, 1 week ago
Money Control, 2 weeks ago
Money Control, 2 weeks ago
Business Standard, 3 weeks ago
Reuters, 18 hours ago
Money Control, 3 weeks ago
Reuters, 18 hours ago
Reuters, 23 hours ago
Business Standard, 5 days ago
Reuters, 2 weeks ago

Lupin gets 3 observations from USFDA for Goa plant

Drug firm Lupin today said the US health regulator FDA has issued three observations after inspecting its Goa plant.
 DNA1 day ago Ajanta Pharma soars after US FDA issues no observations at Dahej plant  Money Control2 weeks ago Lupin’s Aurangabad plant to be inspected by USFDA from April 17: Sources  Money Control3 weeks ago Lupin gets nod for Wellbutrin XL generic from Goa plant post inspection  Money Control2 weeks ago
Business Standard

US FDA issues warning letter for Divi's Laboratories' Visakhapatnam unit

Last month, US drug regulator had issued an import alert on the products manufactured from this unit BS B2B Bureau | Hyderabad April 24, 2017 Last Updated at 15:15 IST The Hyderabad-based active pharmaceutical ingredients (APIs) maker Divi's Laboratories has ...
 Business Standard5 days ago US FDA issues warning letter to Mylan for Nashik facility  Business Standard2 weeks ago US FDA sounds alert on quality issues in Indian pharma  Business Standard3 weeks ago Dr Reddy's Srikakulam unit receives Form 483 with 2 observations  Business Standard3 weeks ago
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Business Standard

Unichem receives US FDA nod for pain killer piroxicam capsule

It will commercialise the product from its Goa plant & source API from its API plant in Roha April 18, 2017 Last Updated at 11:29 IST Unichem Laboratories Limited has received ANDA approval from the US Food and Drug Administration (USFDA) for pain killer drug ...
 Business Standard1 week ago Dr.Reddy#39;s clears US FDA audit at API plant in SEZ, Srikakulam  Money Control2 weeks ago Dr Reddy#39;s clears US FDA audit at API plant in SEZ, Srikakulam  Money Control2 weeks ago Dr Reddy#39;s gains over 4% on buzz Srikakulam API plant cleared US FDA audit  Money Control3 weeks ago
Sify

BUZZ-India's Aurobindo Pharma hits more than 2-mth low on US FDA observations

** Shares of Aurobindo Pharma Ltd fall as much as5.01 pct to lowest since Feb. 16; top pct loser on NSE index ** U.S. Food and Drug Administration (U.S. FDA) issues Form483 with six observations after inspection at Aurobindo'sformulations making unit in ...
 Sify1 week ago BUZZ-India's Dr. Reddy's Labs rises; FDA has no observations for plant  Sify1 week ago Dr. Reddy's Labs rises; FDA has no observations for plant  Sify1 week ago BUZZ-India's Dr. Reddy's Labs hits 2-1/2-yr low on U.S. FDA observations  Sify1 month ago

Glenmark plans new launches in US, receives FDA nod for anticoagulant drug

Pradaxa is Glenmark's fourth product approval in the US from January till date
 Business Standard1 week ago BUZZ-India's Cadila Healthcare surges; U.S. FDA unit inspection ends successfully  Sify2 months ago Cadila Health up 3% on product launch USFDA nod to skin drug  Money Control2 months ago Cadila shares extend gains; surge over 7 pc  Business Standard2 months ago
Money Control

Dr Reddy#39;s gets two USFDA observations for Srikakulam plant

The company said was addressing the observations raised by US FDA without specifying the nature of those observations.
 Money Control3 weeks ago Here’s what analysts feel about Dr Reddy’s Labs post US FDA observations  Money Control1 month ago Dr Reddy's Miryalaguda plant observations minor: Edelweiss  Money Control1 month ago Unichem gets two US FDA observations for its Ghaziabad plant  Money Control1 month ago
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Money Control

Details of US-FDA letter issued to Indoco Remedies#39; Goa plant become public

Indoco Remedies is in focus as details of warning letter issued by US-FDA to company#39;s Goa plant II and III become public. Watch Ekta Batra of CNBC-TV18 gives more details.
 Money Control2 weeks ago Impact of FDA warning letter on sales minimal, to reply in 15 days: Indoco Remedies  Money Control3 weeks ago Indoco Remedies gets warning letter from USFDA for Goa plant  Business Standard4 weeks ago
Business Standard

US FDA agrees to fast track trial process for Wockhardt's superdrug

Wockhardt to start phase III clinical trial for antibiotic WCK 5222, used for treating superbug BS B2B Bureau | Mumbai April 7, 2017 Last Updated at 17:06 IST The US Food & Drug Administration (FDA) has agreed to abridged clinical trial for phase III for ...
 Business Standard3 weeks ago Wockhardt shares up 7% as USFDA fast-tracks its new antibiotic in clinical trial  Money Control3 weeks ago Sensex, Nifty could see a strong start; Wockhardt in focus  Money Control1 month ago
Money Control

US FDA records 11 observations at Sun Pharmaceutical#39;s Dadra unit

The US FDA has recorded 11 observations at Sun Pharmaceutical#39;s Dadra based formulations manufacturing site.
 Money Control2 weeks ago Glenmark Pharma's Ankleshwar plant gets 4 FDA observations  DNA2 months ago Sun Pharma's Dadra facility receives 11 USFDA observations after inspection  Business Standard6 days ago
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