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About 389 results for "usfda"

Cadila Healthcare says Zydus got USFDA nod to market two drugs
Business Standard

Lupin gains on USFDA approval for Tydemy that uses to prevent ...

Tydemy is indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Money Control, 3 days ago
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118 images for usfda

Business Standard, 5 days ago
Money Today, 6 days ago
Money Today, 1 week ago
Money Control, 4 days ago
Business Standard, 4 days ago
Business Standard, 4 days ago
Money Today, 2 weeks ago
Money Control, 5 days ago
Money Control, 5 days ago
Business Standard, 5 days ago
Business Standard

Dr Reddy#39;s stock surges 6% on receiving EIR from USFDA

The company yesterday said it has received an EIR from USFDA on December 11 as closure of audit for its formulations manufacturing plant - 3 at Bachupally, Hyderabad. Dr Reddy#39;s was issued a form 483 with 11 observations.
 Money Control5 days ago Dr Reddy's gains 6% on receiving EIR from USFDA for Hyderabad facility  Business Standard6 days ago Biocon surges 14% on USFDA nod for biosimilar of cancer drug  Business Standard2 weeks ago Biocon surges 14% on USFDA approval for biosimilar of cancer drug Herceptin  Business Standard2 weeks ago
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Money Control

Dr Reddy#39;s Lab up 6% on establishment inspection report from USFDA for Bachupally unit

The clearance to plant indicated that the company resolved all observations pointed by the US health regulator.
 Money Control5 days ago Dr. Reddy's Lab gets EIR from USFDA for Hyderabad facility  Myiris6 days ago Dr Reddy's spurts after getting EIR for Bachupally facility  Business Standard6 days ago Dr Reddy#39;s Laboratories up 2% on EIR from USFDA for Telangana unit  Money Control2 weeks ago
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Money Today

Shilpa Medicare declines 6% as USFDA issues 10 observations for Telangana facility

The company has received 483 observations from the United States Food Drug Administration (USFDA) in relation to SEZ formulation facilities situated at Jadcherla, Telangana (near Hyderabad).
 Money Control1 week ago Shilpa Medicare tanks over 4% on USFDA observations  Money Today1 week ago Shilpa Medicare slips after USFDA issues 10 observations  Business Standard1 week ago Shilpa Medicare update on USFDA inspection of facility at Jadcherla, Telangana  Business Standard1 week ago

Rhizen receives USFDA fast track designation for cancer drug

"The US Food and Drug Administration (USFDA) has granted Fast Track Designation for RP6530 (tenalisib)...for the treatment of patients with relapsed/refractory peripheral T- cell lymphoma (PTCL)," Alembic Pharmaceuticals said in a BSE filing.
 Money Control1 week ago
Money Control

Cadila Healthcare shares gain on USFDA approval for Clozapine that treats schizophrenia

Clozapine tablets will be manufactured at group#39;s formulations manufacturing facility at SEZ, Ahmedabad.
 Money Control1 week ago Cadila Healthcare shares gain 4% on USFDA approval for ADHD drug  Money Control1 month ago
Money Today

Glenmark Pharmaceuticals stock falls over 3% on USFDA's observations over Baddi unit

Glenmark said its Baddi unit contributes approximately 10 per cent of the revenue of the US sales. At 2:43 pm, the stock was trading over 3 percent or 18 points lower at 573.30 on the BSE. The stock is down 35.45 percent on year to date basis. On an yearly ...
 Money Today2 weeks ago Glenmark Pharma slips 3% on observations issued by USFDA for Baddi plant  Money Control2 weeks ago Glenmark Pharmaceuticals update on USFDA audit of Baddi unit  Business Standard2 weeks ago Glenmark Pharma falls 3% as Baddi unit gets 7 observations from USFDA  Business Standard2 weeks ago
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Business Standard

USFDA issues warning letter to Lupin's Goa, Indore plants

USFDA issued a warning letter to Lupin for violation of current good manufacturing practice norms at two of its manufacturing facilities in Goa and Indore Press Trust of India | New Delhi Last Updated at November 16, 2017 19:39 IST The US Food and Drug ...
 Business Standard1 month ago Lupin stock falls over 18% after USFDA issues warning letter  Money Today1 month ago Lupin to engage consultants and site-transfer dozen products to contain fallout of USFDA warning letter  Money Control1 month ago Lupin touches 52-week low on warning letter from USFDA to Goa Indore sites  Money Control1 month ago

Biocon jumps after receiving EIR from USFDA

after the company said its facility has been cleared by the US drug regulator after an inspection. The announcement was made before trading hours today, 20 November 2017. Meanwhile, the S BSE Sensex was up 5.10 points, or 0.02% to 33,347.90. On the BSE, 2.39 ...
 Business Standard4 weeks ago Biocon receives EIR for its aseptic drug product facility  Business Standard4 weeks ago Biocon gains 5.6% on EIR from USFDA  Money Control4 weeks ago Biocon#39;s facility receives EIR with VAI status, inspection closed  Money Control4 weeks ago

Alkem Labs up 8% as Motilal Oswal upgrades to buy on domestic biz; USFDA nod for Capecitabine

Motilal Oswal has hiked its price target on the stock to Rs 2,500 per share (from Rs 1,950) as it expects domestic business to grow at 20 percent over the next three quarters.
 Money Control2 weeks ago Divis Labs jumps 5% as Axis Capital upgrades, hikes target sharply post USFDA audit  Money Control2 months ago
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