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US FDA Approval

Nine Observations given to Dr Reddy’s Laboratory at Srikakulam Plant by USFDA

New Delhi, Dec 31, 2014: US FDA recently visited Dr Reddy’s Laboratories manufacturing facility at Srikakulam district which is the bulk manufacturer of active pharmaceutical ingredients and bulk drugs. The US FDA regulators have given nine inspectional observations through form...

Cadila gets USFDA nod to market arthritis drug

The group has now 88 approvals and has so far filed 216 ANDAsNew Delhi January 31, 2014: Drug firm Cadila Healthcare today said it has received US health regulator's nod to market Etodolac extended release tablets, used in the treatment of arthritis,...

Jubilant Life gets US FDA approval for Canada Plant

New Delhi, March 10, 2014 : Jubilant Life Sciences has 10 manufacturing facilities in India, US and Canada and is involved in manufacturing active pharmaceutical ingredients (APIs), generics, specialty pharmaceuticals and life science ingredients. It also provides services...

Issuance of Form 483 by US FDA to IPCA Laboratories not the First Time

New Delhi, Dec 31, 2014:  Recently on 19 December 2014, The Silvasa facility of IPCA Laboratories received Form 483 having 5 observations by US FDA. However according to the documents of USFDA this is not the first time the...

Ranbaxy sues the US FDA for revoking two key drug approvals

Washington, 24 Mar, 2015: The Indian drug manufacturer Ranbaxy, based in Haryana, has sued the US Food & Drug Administration (US FDA) for allegedly wrongfully revoking the approvals to two of its key drugs — Valcyte (Roche) and Nexium (AstraZeneca)...

Health Canada asks Ipca to stop ingredients shipment

USFDA detected data manipulation by the company Mumbai, September 24, 2014 - Just months after Ipca voluntarily stopped the export of pharmaceutical ingredients to the United States, the drugmaker has been asked by Health Canada to stop similar shipments to...

Dr Reddy’s files new drug application with USFDA

Hyderabad, April 13, 2015 Dr Reddy's Laboratories and its subsidiary, Promius Pharma today announced filing of three new drug applications (NDAs) with the US Food and Drug Administration. Of the three, two are related to dermatology (skincare) applications and one is...

USFDA extends time for Dr Reddy’s to respond on warning letters

Hyderabad, November 27, 2015: The US Food and Drug Administration (USFDA) has extended deadline for Dr Reddy’s laboratories Ltd to respond to its warning letters till December 7, 2015. The Hyderabad-based Dr Reddy's informed this to the Bombay Stock Exchange...

Compliance does not end with approval, says US FDA chief

Says US regulator plans to expand its India presenceNew Delhi February 12, 2014:- Compliance does not end with approval, visiting US Food and Drug Administration (US FDA) Commissioner Margaret Hamburg told Business Standard, replying to a question on tough and repeated...

Aurobindo gets USFDA nod for antibiotic

Mumbai, August 04, 2018: Aurobindo Pharma said on 5 June it has received approval from the US Food and Drug Administration (USFDA) for its antibiotic drug Cefpodoxime proxetil in multiple strengths. This is the sixth such approval for the company,...