Tag Archives: US Food & Drugs Administration

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

GLENMARK PHARMA gets USFDA nod to market SKIN-TREATMENT product

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered Glenmark Pharmaceuticals Ltd said of having got final approval from US FDA (Food & Drugs Administration) to sell dermatology (skin-treatment) product. The press-release as submitted by the company to the Indian Stock Exchanges – titled, “Glenmark Pharmaceuticals

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 –

LUPIN launches anti-depressant drug

BALTIMORE (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered pharma major Lupin Ltd said of having launched anti-depressant drug of which the approval to market the product, was received earlier from US FDA (Food & Drugs Administration). The press-communication as addressed to the

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

Zydus announces patient enrollment in clinical trials of Saroglitazar

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Ahmedabad headquartered Indian Pharma major Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Group) said of having enrolled patient(s) in evidences VII phase 2 clinical trial of Saroglitazar Magnesium. The company-statement submitted to the Indian Bourses, titled – “Zydus

USFDA slams Form 483 with 8 observations to VIZAG unit of Dr Reddy’s Labs

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Hyderabad headquartered Indian Pharma major having global presence said of its VIZAG plant getting inspected by US FDA (Food & Drugs Administration) and the regulators have slammed From 483 with 9 observations. The company statement submitted to

USFDA clears Alembic Pharma’s Bioequivalence facility, no 483 observations

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Vadodara headquartered Indian Pharma major Alembic Pharmaceuticals Ltd said of its Bioequivalence facility being inspected by USFDA and no 483 observations issued. The company-statement submitted to the Indian Bourses read that, This is to inform the

SeQuent Scientific’s Bengaluru facility gets Establishment Inspection Report

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company SeQuent Scientific Ltd said of its Bengaluru facility getting clearance post inspection by US FDA (Food & Drugs Administration) and getting Establishment Inspection Report (EIR). The press-statement submitted by the company -titled, “SeQuent Scientific receives

In US, Dr Reddy’s launches powder for oral solutions, to treat eye-diseases

PRINCETON (NEW JERSEY – US) | HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Hyderabad headquartered Indian Pharma major Dr. Reddy’s Laboratories Ltd announced launch of powder in US, used for oral solutions, to treat eye-related disorders. The press-release submitted by the company to the

Dr Reddy’s Labs launches biosimilar in India, for cancer-treatment

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press-statement submitted to the Indian Stock Exchanges, Hyderabad headquartered Pharma Major Dr. Reddy’s Laboratories Ltd said of having announced launch of Versavo® in India, used to treat and cure several types of cancers. Press-statement submitted by the company to the Indian Bourses titled, “Dr. Reddy’s Laboratories

Glenmark Pharma gets USFDA nod to market diabetes treatment drug

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT  – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Indian pharma major Glenmark Pharmaceuticals Ltd said of having got US FDA (Food & Drugs Administration) nod to market diabetes treatment drug. Press-release titled, “Glenmark receives approval for combination of Remogliflozin Etabonate and Metformin Hydrochloride for adults

Lupin gets USFDA nod to market dermatology (skin disease) treatment cream

BALTIMORE (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered Indian Pharma major Lupin Ltd said of having got nod from USFDA to market dermatology treatment. The press-statement submitted to the Indian Bourses by the company titled, “Lupin receives U.S. FDA approval for Hydrocortisone

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

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