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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...

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...

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...

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,...

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...

Panacea Biotec Ltd receives EIR from USFDA for Oncology plant at Malpur, Baddi

Mumbai, March 15, 2018: Pharma Major, Panacea Biotec Ltd. has announced the receipt of Establishment Inspection Report (EIR) from the U.S. Food & Drug Administration ('USFDA') indicating the formal closure of the Inspection conducted by USFDA, at its Pharmaceutical...

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...

USFDA finishes pre-endorsement investigation at Biocon Malyasia

Mumbai, February 24, 2018: Pharma Noteworthy, Biocon said that USFDA has finished a pre-endorsement investigation of its assembling office in Malaysia and issued a Frame 483 with 6 perceptions According to the typical desires of the organization, we plan to...