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US FDA Approval

FDA approves device to automatically manage diabetes

Washington, October 02, 2016: Federal regulators have approved a first-of-a-kind implant that can help some diabetes patients manage their disease, freeing them from the ordeal of constantly monitoring their blood sugar. The so-called artificial pancreas continuously measures blood sugar and...

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...

Glenmark gets USFDA nod for generic diabetes treatment drug

New Delhi, June 01, 2015 Glenmark Pharmaceuticals today said it has received the final approval from US health regulator for its generic version of Desmopressin Acetate tablets used in the treatment of diabetes and bed-wetting. The approval by the US Food...

Tuberculosis -The Scourge Of India By Dr. Shalu Verma Kumar, CORE Diagnostics

New Delhi, March 14, 2018: Tuberculosis (TB) is an infectious disease variously named consumption, white plague, phthisis, or scrofula. It has been rampant in India, with the first cases being reported as early as 1500 BCE. As we celebrate the...

Jubilant Life Sciences receives ANDA approval for Telmisartan Tablets

New Delhi, August 29, 2016: Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has announced that it has received Abbreviated New Drug Application (ANDA) final approval for Telmisartan Tablets, USP 20,40 and 80mg, the generic...

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,...

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...

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...

Strides clarifies on FDA alert

Bangalore, October 07, 2014 - Strides Arcolab has clarified that it has no role in distributing certain products manufactured by its subsidiary and that these products found its way into the US markets without their knowledge. Earlier in the day, the...

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...