Tag Archives: US Food & Drugs Administration
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 mkt tablets to treat excess iron
MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Indian Pharmaceutical company Glenmark Pharmaceuticals Ltd said of having got nod from USFDA (US Food and Drugs Administration) to market tablet to treat excess iron in the body, usually such iron overload is created due to blood transfusion in adults
USFDA inspects INDOCO REMEDIES’ Goan plants gives EIR
MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Indoco Remedies Ltd said of its Goan plants inspected and having received Establishment Inspection Report (EIR). In a press-release submitted to the Indian Bourses, titled – “Indoco receives EIR for its manufacturing facilities in Goa (Plant II
ALEMBIC PHARMA gets USFDA nod to sell tablets to treat iron levels in blood
VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Vaoddara headquartered pharmaceutical products manufacturing company Alembic Pharmaceuticals Ltd said of having got nod to market medicine to treat iron levels in blood, especially to treat chronic iron overload due to blood transfusions in patients of
CADILA HEALTH (ZYDUS) gets USFDA nod to market medicine for cardiac cure & skin treatment
AHMEDABAD | MUMBAI | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Ahmedabad headquartered Cadila Healthcare Ltd (Dr Pankaj Patel lead Zydus Cadila Group) said of having got nod from USFDA (US Food & Drugs Administration) to market medicines to cure cardiac problems and skin-treatment. In a press-release as submitted by
STRIDES PHARMA : USFDA announces Lab testing & analysis of Ranitidine Tablets
MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Mumbai headquartered Pharma company Strides Pharma Science Ltd said of having its Rantidine Tablets tested by USFDA and the regulator has announced testing & analysis results of the company terming as NDMA (nitrosodimethylamine) levels with acceptable limits. The company
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