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US FDA Approval

Lupin gets USFDA nod for generic version of Mycobutin capsules

The drug is used for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection New Delhi February 28, 2014:- Pharmaceutical firm Lupin Ltd. on Wednesday said it has received final approval from the US health regulator...

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...

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...

FDA recalls injectable Vitamin Products distributed by Medical Supply Liquidators

New Delhi, July 11, 2014 - The U.S. Food and Drug Administration (FDA)has warned health care professionals not to use injectable vitamin products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. These...

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...

Aurobindo Pharma receives USFDA Approval for Linezolid Injection

New Delhi, August 29, 2016: Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Linezolid Injection, 600 mg/300 mL (2 mg/mL). The...

Lupin gets US FDA nod for Pioglitazone tablets

NEW DELHI, APRIL 10, 2014: Lupin today said that it has received final approval from the US health regulator to sell generic diabetes management drug Pioglitazone tablets in the American market. Lupin said its US subsidiary, Lupin Pharmaceuticals Inc,...

Lupin to sell generic HIV drug

New Delhi, Jan 05, 2015 Lupin Ltd announced that it has received a tentative approval from the US Food and Drug Administration (FDA) to market a generic version of the Prezista tablets, which are used for the treatment of HIV-1...

Zydus Cadila gets USFDA nod to market two drugs

 Ahmedabad January 10, 2014: Ahmedabad-based firm has also received USFDA approval to market Duloxetine delayed release capsules in different strengthsAhmedabad-based Zydus Cadila received the final approval from the US drug regulator to market one immuno-supressant and one anti-depressant drug in the...

US FDA to speed up approvals for Indian drug-makers

Mumbai February 13, 2014: US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has said that strengthening relations with India, which provides generic medicines to almost 200 countries and is the second largest exporter of generic medicines to the...