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US FDA News

The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. (Representative image)

USFDA inspection of company’s US plant completed successfully: Torrent Pharmaceuticals

Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator has observed any…

December 16, 2021 16:42 IST

FDA publishes draft guidance on assessing adhesion with TDS and topical patches for ANDAs

Updated recommendations are provided for the statistical analysis of adhesion scores and results The FDA has published the draft guidance…

June 2, 2016 11:19 IST

Claris announces receipt of EIR from US FDA

The US FDA had conducted audit at Claris’ manufacturing facility near Ahmedabad in May 2015 Sterile injectables company; Claris Lifesciences…

May 30, 2016 16:59 IST

Lupin announces closure of US FDA audits for its Mandideep and Aurangabad facilities

The US FDA had conducted audits at Lupin’s Mandideep facility from February 8-19, 2016 and its Aurangabad facility from January…

May 27, 2016 11:41 IST

Indoco Remedies receives US FDA nod for Goa manufacturing facility

The approval confirms the closure of inspection conducted in July 2015

May 26, 2016 12:15 IST

Dr Reddy’s recalls 50k bottles of Ondansetron tabs in US

The ongoing recall was initiated on March 30, 2016

May 18, 2016 17:26 IST

Pharma exports growth heading for a sharp decline: CRISIL Research

As game changes, companies need to redraw long-term strategies and focus on innovation

May 17, 2016 14:56 IST

Pfizer signs definitive merger agreement with Anacor Pharmaceuticals

To acquire Anacor Pharmaceuticals for $5.2 billion Pfizer and Anacor Pharmaceuticals have entered into a definitive merger agreement under which…

May 17, 2016 12:38 IST

Aurobindo Pharma gets US FDA nod for anaesthetic injection

The product is expected to be launched in the second quarter of 2016-17 fiscal, it added

May 16, 2016 14:40 IST

Embracing quality as an opportunity

Concerned with declining pharma exports in the recent past, the Ministry of Commerce & Industry has tried to burnish the…

Updated: May 20, 2016 20:36 IST

US FDA warns Sri Krishna Pharma, citing drug-data manipulation

Sri Krishna Pharmaceuticals, a supplier of paracetamol and other drugs to more than 60 countries, has been warned by the…

Updated: April 20, 2016 13:58 IST

Alembic Pharma receives FDA observations for Panelav plant

The company, however, did not provide any details about the observations

April 19, 2016 10:45 IST

Pharma sector likely to report good growth for Q4 of last fiscal

According to a report in Centrum Broking, the domestic pharma market will gain from price increase, volume growth and new…

April 13, 2016 10:58 IST

Sun Pharma receives US FDA approval for BromSite

First NSAID approved for prevention of ocular pain in patients undergoing cataract surgery

April 11, 2016 12:04 IST

FDA approves Micra, the first leadless pacemaker to treat heart rhythm disorders

The self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart The US Food and Drug…

April 7, 2016 17:14 IST

Glenmark receives US FDA approval for bendamustine hydrochloride injection

It is Glenmark’s first injectable approval in the US

March 28, 2016 11:07 IST

Indoco Remedies receives USFDA nod for solid dosages plant I in Goa

The plant has a capacity to manufacture 2.2 billion tablets, 32 million bottles of liquid orals, 16 million tubes of…

March 22, 2016 10:50 IST

‘We compete against world class producers from the US and Japan’

Neelikon has emerged as a prime manufacturer of high quality colourants for food colour, pharmaceutical colours, cosmetic colours, personal care…

March 21, 2016 14:43 IST

Lupin completes acquisition of GAVIS

The combined company will have a portfolio of over 120 in-market products, over 185 cumulative filings pending approval and a…

March 9, 2016 14:29 IST

Ajanta Pharma gets US FDA nod for migraine pain relief drug

Ajanta Pharma USA is scheduled to launch the almotriptan malate tablets in the US shortly Ajanta Pharma has received final…

Updated: March 7, 2016 13:49 IST

Zydus receives US FDA approval for Glyburide and Metformin Hcl tabs

The formulations manufacturing facility at Baddi will produce the drug for the US market

March 2, 2016 11:04 IST

Aurobindo Pharma receives US FDA approval for Acetylcysteine injection

The product is likely to be launched in Q1 FY16-17

March 1, 2016 14:08 IST