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About 274 results for "us fda"

USFDA to lift barriers on generic drug competition to address pricing problem
Money Control

USFDA to lift barriers on generic drug competition to address ...

As an antidote to rising drug prices, US-FDA is working on plan to increase generic competition. This move is likely to bring in increased pricing pressure for Indian pharma companies. Money Control, 4 days ago

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Money Control, 6 days ago
Business Standard, 1 week ago
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Money Control

Pharmacovigilance unit of Ipca Laboratories receives EIR from US FDA: Sources

CNBC-TV18 learns that the United States Food and Drug Administration (USFDA) is likely to have issued Establishment Inspection Report (EIR) for Ipca Laboratories#39; pharmacovigilance unit in May-June.
 Money Control3 days ago Dr Reddy#39;s may file two new drugs with FDA by 2019  Money Control6 days ago Dr Reddy's may file two new drugs with FDA by 2019  Business Standard6 days ago FDA places clinical hold on Concert Pharma's hair loss drug  Reuters1 month ago

US FDA issues 5 observations for Lupin#39;s Pithampur Unit 3

The US Food and Drug Administration (US FDA) issues 5 observations for Lupin#39;s Pithampur Unit 3. In an interview to CNBC-TV18, Amey Chalke, Research Analyst at HDFC Securities shared his readings and outlook on the same.
 Money Control4 days ago US FDA issued 3 observations to Srides Shasun#39;s Bangalore unit  Money Control2 weeks ago Dr Reddy's Srikakulam unit receives Form 483 with 2 observations  Business Standard2 months ago

US FDA approves Glenmark Pharma's drug for overactive bladder

The scrip was trading 0.79 per cent higher at Rs 633.65 on the BSE
 Business Standard4 days ago
Money Control

US FDA ban 'withdrawal of exemption' due to changed supply situation: Ipca

US FDA has not carried out any new inspection or re- inspection of the company's manufacturing units
 Business Standard6 days ago Ipca says US FDA import ban on drugs relates to change in supply shortage in US  Money Control6 days ago
Money Control

Dr.Reddy#39;s gets EIR for Miryalaguda plant, indicating closure of USFDA audit

The plant was inspected by USFDA from February 13-21 and had received three Form 483 Observations from US FDA. Miryalaguda plant called at CTO Unit V was one among the three plants.
 Money Control1 week ago Vivimed Labs zooms 8% on zero US FDA observations for Spain facility  Money Control2 weeks ago Lupin gets 3 observations from USFDA for Goa plant  DNA1 month ago Ajanta Pharma soars after US FDA issues no observations at Dahej plant  Money Control2 months ago
Money Today

FDA moves to prevent Pharma from 'gaming' generic drug system

The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from "gaming" the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting ...
 Reuters4 days ago US bans imports of drug from three Ipca Lab facilities; shares fall  Money Today1 week ago Reduce call on Sun Pharma, target price lowered to Rs 501: Prabhudas Lilladher  Money Control1 week ago FDA rejects Coherus' biosimilar for Amgen's Neulasta  Reuters2 weeks ago
Money Control

Dr Reddy’s US FDA developments get a thumbs up from brokerages

Cite positive news on the regulatory front, but pain for Duvvada plant may remain, they say.
 Money Control1 week ago Dr.Reddy#39;s clears US FDA audit at API plant in SEZ, Srikakulam  Money Control2 months ago Dr Reddy#39;s clears US FDA audit at API plant in SEZ, Srikakulam  Money Control2 months ago Dr Reddy#39;s gains over 4% on buzz Srikakulam API plant cleared US FDA audit  Money Control2 months ago
Money Control

Alkem Labs, Wockhardt shares gain 2-4% on drug approvals from USFDA

Wockhardt has received tentative approval from US FDA for Bendamustine Hydrochloride injectable, which is used in treatment of different types of cancer.
 Money Control1 week ago US FDA approves new eczema drug Dupixent  Business Standard2 months ago

Natco may have to wait longer to launch copy of multiple sclerosis drug Copaxone in US

The launch is likely to get further delayed as US drug regulatory agency FDA sought more information from its partner Mylan on its filing.
 Money Control1 week ago
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