Tag Archives: US Food & Drugs Administration
CADILA HEALTH ink pact with GILEAD SCIENCES to mfr & mkt REMDESIVIR
AHMEDABAD / MUMBAI / RAJKOT – In a regulatory filing as submitted to the Indian Stock Exchanges from Ahmedabad headquartered Pankaj Patel led Zydus Group’s Healthcare Services providing, Pharmaceutical and Wellness products manufacturing Indian company Cadila Healthcare Ltd it said of having inked non-exclusive licensing agreement with Gilead Sciences Inc., to manufacture and market Remdesivir
Dr REDDY’s LAB launches tablets in US, to cure severe joint pains
PRINCETON (NEW JERSEY, US) / HYDERABAD / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered pharmaceutical products manufacturing Indian company Dr Reddy’s Laboratories said of launching Colchicine Tablets in the US market, Colchicine Tablets are used to treat severe joint pains in the US Market. In
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
IND-SWIFT LABS’ Derabassi (Punjab) cleared by USFDA, gets EIR
CHANDIGARH / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Chandigarh headquartered pharmaceutical products manufacturing Indian company Ind-Swift Laboratories Ltd said of having got Establishment Inspection Report (EIR) from USFDA (US Food and Drugs Administration) for its Derabassi plant located in the state of Punjab, in India. In
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