Last Updated : Thursday, June 11, 2020 16:44:20

Tag Archives: abbreviated new drug application

LUPIN gets USFDA nod to sell medicine to treat liver, lung disorders

BALTIMORE (US) / MUMBAI / RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing Indian company Lupin Ltd said of having got USFDA (US Food & Drugs Administration) nod to treat liver and lung disorders. In a press-release titled, “Lupin Receives Approval for Albendazole Tablets USP”, as

CADILA HEALTH gets USFDA nod to market tablets to treat Parkinson’s disease

AHMEDABAD / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Ahmedabad headquartered Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) got USFDA (US Food and Drugs Administration) nod to market tablet to treat Parkinson’s disease or Parkinson’s like symptoms. In a company press-release titled, “Zydus receives

STRIDES PHARMA to acquire 18 ANDAs from Pharmaceutics International, Inc.

BENGALURU | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bengaluru headquartered Indian Pharmaceutical products manufacturing company Strides Pharma Science Ltd said of having acquired 18 abbreviated new drug applications (ANDA) from Pharmaceutics International, Inc., for a transaction value of approximately US Dollars $6.1 million, of which US

GLENMARK PHARMA gets USFDA nod to market skin & pimple care treatment

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press-release submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company Glenmark Pharmaceuticals Ltd said of having got nod from USFDA (US Food & Drugs Administration) to market skin & pimple care treatment. The press-release as submitted by the company to the Indian Bourses – titled, “Glenmark

USFDA issues warning, initiates official action against LUPIN’s Mandideep unit

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Indian Pharma major Lupin Ltd said of US FDA (Food & Drugs Administration) having issued warning letter and initiated official action against Mandideep facility of the company. The company update as submitted to the Indian Bourses read

UNICHEM LABS gets USFDA nod to market URINARY disorder treatment

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered Unichem Laboratories Ltd said of having got nod from US FDA (Food & Drugs Administration) to market drug to treat urinary disorders. The company statement submitted to the Indian Bourses read that, Unichem Laboratories Limited is pleased to

STRIDES PHARMA acquires USFDA approved manufacturing facility in the US

BENGALURU | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Bengaluru & Mumbai headquartered Indian Pharma Major, Strides Pharma Science Ltd said of having acquired US FDA (Food & Drugs Admininstration) approved manufacturing facility at Riviera Beach (Florida) in The United State of America. The press-release as

GLENMARK gets USFDA nod to market medicine to treat BREAST-CANCER

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update filing sumitted to the Indian Stock Exchanges, Mumbai headquartered Indian Pharma company Glenmark Pharmaceuticals Ltd said of having got approval from US FDA (Food & Drugs Administration) to market injections to treat breast-cancer. The press-communication submitted by the company to the Indian Bourses titled –

Cadila gets USFDA nod to market blood-pressure, heart disease treatment drug

AHMEDABAD | MUMBAI | RAJKOT – In a press-release submitted to the Indian Stock Exchanges, Ahmedabad headquartered pharma major Cadila Healthcare Ltd (Dr. Pankaj Patel led Zydus Cadila Group) said of having got approval from US FDA (Food & Drugs Administration) to market tablets to treat blood-pressure and heart disease. The press-statement, as addressed by

Patent Infringement case filed against Sun Pharma

NEW JERSEY (US) | VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Indian Pharma major Sun Pharma Advanced Research Company (SPARC) Ltd said of complaint filed at one of the US District Courts at New Jersy, against the company, alleging patent

Alembic Pharma gets USFDA nod to market drug to treat cholestoral levels

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR-RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Indian pharma major, Alembic Pharmaceuticals Ltd said of having got nod from US FDA (Food & Drugs Administration) to market drug to treat cholesterol related disorders. The press-statement titled, “Alembic Pharmaceuticals receives USFDA Approval for

Unichem Laboratories gets USFDA nod to market pain-killer durg

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered pharma major Unichem Laboratories Ltd said of having got US FDA (US Food & Drugs Administration) nod to market pain-killer drug. The press-statement submitted by the company to the Indian Bourses read that, Unichem Laboratories Limited is pleased

Alembic Pharma gets USFDA nod to market eye-disease treatment solution

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR-RAJKOT – In a press release submitted to the Indian Stock Exchanges, Vadodara (Baroda) Gujarat headquarted Indian Pharma company Alembic Pharmaceuticals Ltd said of having got US FDA (Food & Drugs Administration) nod to market ophthalmic (eye-disease treatment) solution. The press release submitted by the company read that, Alembic Pharmaceuticals receives

USFDA clears Indoco Remedies’ Goa Plant II & III, despite four 483 observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Bourses, Mumbai headquartered Indoco Remedies said of its Goa plant inspected by US FDA (Food & Drugs Administration) and the plant – II & III have been cleared, despite the fact that company had received four 483 observations. The press release

Zydus Cadila gets USFDA nod to market sedative/hypnotic (sleep disorder treatment drug)

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses, Ahmedabad headquartered Dr. Pankaj Patel led Cadila Healthcare Ltd (Zydus Cadila Group) said of having got nod from US FDA (Food & Drugs Administration) to market drug to treat insomnia (sleep related disorders) The press release submitted by the company

Dr. Reddy’s Labs gets USFDA nod to market insomnia treatment drug

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Bourses, Hyderabad based Indian pharma major Dr. Reddy’s Laboratories Ltd said of having got US FDA (Food & Drugs Administration) nod to market drug to treat insomnia (troubles having to fall asleep). The press release submitted to the Indian Stock

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