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May 22, 2019 03:08 PM IST
The company has launched its generic product after receiving the approval from the USFDA.
May 21, 2019 11:15 AM IST
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Solifenacin Succinate tablets in the strengths of 5 mg and 10 mg, Alembic Pharmaceuticals said in a BSE filing.
May 19, 2019 12:45 PM IST
Seven Indian drug makers have been named in a US antitrust lawsuit alleging a conspiracy to artificially inflate and manipulate prices, reduce competition and unreasonably restrain trade for over 100 generic drugs.
May 15, 2019 05:33 PM IST
The USFDA carried out the inspection at the plant from May 6 to May 15.
May 15, 2019 02:40 PM IST
The company has launched its product, which is generic version of Merck Sharp & Dohme Corp's Cubicin, after obtaining approval from the US Food and Drug Administration (USFDA), the Hyderabad-based firm said in a statement.
May 14, 2019 10:50 AM IST
The approved products is a generic version of AstraZeneca Pharmaceuticals' Nexium delayed-release capsules.
May 12, 2019 11:58 AM IST
The company is also recalling 164,424 bottles of Losartan Potassium tablets, USP, 50 mg from the US and Puerto Rico, the regulator said.
May 08, 2019 11:24 AM IST
As per IQVIA data, Nitroglycerin Sublingual Tablets had total annual sales of around $77.3 million in the US market, for the year ending 2018.
May 07, 2019 05:01 PM IST
The company has received tentative approval from the USFDA to market its Fosaprepitant for injection in the strength of 150 mg single-dose vial.
May 06, 2019 01:35 PM IST
According to the USFDA, an OAI means regulatory and/or administrative actions will be recommended for the facility which was inspected after it determines if the areas evaluated were in compliance with applicable laws and regulations.
May 05, 2019 10:36 AM IST
Lupin Somerset is recalling the drug in various strengths due to "failed impurities/degradation specifications", the latest enforcement report by the USFDA said.
May 02, 2019 02:42 PM IST
The health regulator had inspected the company's Dadra facility from March 22 - March 29, 2019; and at the conclusion of the inspection, had issued a Form 483, with 11 observations to the company.
April 30, 2019 05:58 PM IST
The approval by the United States Food and Drug Administration (USFDA) is for marketing Bosentan tablets in the strengths of 62.5 mg and 125 mg, Lupin said in a statement.
April 30, 2019 10:41 AM IST
Cipla's Ambrisentan tablets 5 mg and 10 mg is AB-rated generic therapeutic equivalent version of Gilead Sciences Inc's Letairis.
April 25, 2019 03:18 PM IST
The company has received final approval from the USFDA to market Leflunomide tablets in the strengths of 10 mg and 20 mg.
April 23, 2019 08:20 PM IST
The Mumbai-based drugmaker, however, said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility.
April 22, 2019 01:20 PM IST
The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, Alembic Pharmaceuticals said in a filing to BSE.
April 21, 2019 12:34 PM IST
The company is also recalling 476,340 bottles of Losartan Potassium tablets USP, 50 mg from these markets.
April 18, 2019 11:10 AM IST
The US Food and Drug Administration (USFDA) has approved its abbreviated new drug application (ANDA) for Acetaminophen 650 mg tablets, extended release, Granules said in a BSE filing.
April 16, 2019 03:22 PM IST
The company has received approval from the US Food and Drug Administration to market its product which is a generic version of Eli Lilly and Company's Prozac tablets.
April 11, 2019 01:12 PM IST
The company has received approval from the United States Food and Drug Administration (USFDA) to market its generic testosterone gel, 1.62 per cent (20.25 mg/1.25 g pump actuation), Lupin said in a statement.
April 10, 2019 03:12 PM IST
As per IQVIA MAT February 2019 data, Fluoxetine tablets 60mg had annual sales of around $41 million in the US, Lupin said.
April 08, 2019 03:00 PM IST
The product is a generic version of Vimpat tablets.
April 08, 2019 11:44 AM IST
In July 2018, Sun Pharma had received approval from the US health regulator for INFUGEM injection.
April 03, 2019 01:10 PM IST
"This is the fifth successive inspection without any 483 observations, indicating superior quality compliance maintained at this global bioresearch facility," Lupin said in a statement.
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