Tag Archives: US Food & Drugs Administration
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
Alembic Pharma gets USFDA nod to market drug to treat diabetis
VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Bourses, Vadodara headquartered pharma major said of having got nod from US food and drug regulator to market drug to treat diabetis. The press release submitted by the comapany to the Indian Stock Exchanges read that, Alembic Pharmaceuticals
Laurus Labs’ exclusive distribution partner gets USFDA nod to market neuropathy treatment drugs
HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Hyderabad headquartered Laurus Labs said of its exclusive distribution partner in US getting rights from US FDA (Food & Drugs Administration) to market neuropathy treatment drug. The press release submitted by the company to the Indian Bourses
Alembic Pharma gets USFDA nod to market neuropathic treatment drug
VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Vadodara (Baroda) Gujarat based pharma major Alembic Pharmaceuticals Ltd said of having received nod from US FDA (Food & Drugs Administration) to market neuropathic & diabetic treatment drug. In the press release submitted to the Indian
Cipla’s subsidiary co gets USFDA nod to market neuropathy treatment drug
NEW YORK (USA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Bourses, pharma major Cipla said of its subsidiary company InvaGen having got nod from US FDA (Food & Drugs Administration) to market neuropathy treatment drug. The press release submitted to the Indian Stock Exchanges read that Cipla’s
USFDA slams Form 483 to Torrent Pharma’s Dahej facility, official action initiated
DAHEJ | AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses late on Wednesday night, Ahmedabad headquartered pharma major Torrent Pharmaceuticals Ltd said of the company having classified as Official Action Initiated by US food & drugs regulator. The Dahej facility of the company was inspected in March 2019
SPARC submits cancer treatment drug for approval to USFDA
VADODARA (BARODA) | MUMBAI | AHMEDABAD – GANDHINAGAR | RAJKOT – In a press release issued to the Indian Stock Exchanges, Vadodara headquartered Sun Pharma Advanced Research Company (SPARC) Ltd said of having filed abbreviated new drug application (ANDA) for caner treatment to USFDA (US Food & Drugs Administration), which has been accepted by the
USFDA inspection at Alkem’s St. Louis (US) facility concluded with observations, regulators indicate official action
ST. LOUIS (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Exchanges, Mumbai headquartered Indian Pharam company Alkem Laboratories Ltd said of the USFDA (US Food & Drugs Administration) concluded inspection at St. Louis (US) facility of the company and that the company will close out all observations
Alembic Pharma gets USFDA nod to market opthalmic (eye treatment) solution
VADODARA (BARODA) | MUMBAI | AHMEDABAD | GANDHINAGAR | RAJKOT – In a press-release submitted to the Indian Exchanges on Monday, Vadodara headquartered pharma major Alembic Pharmaceuticals Ltd said of US Food & Drugs Administration (USFDA) giving nod to the company to market Bimatoprost Ophthalmic Solution, 0.03%. According to IQVIA estimated market size for the
Strides Pharma gets USFDA nod to market Tabs in US, to treat low potassium level in human blood
BENGALURU | MUMBAI | RAJKOT – In a press release submitted to the Indian Stock Markets on Tuesday, Hyderabad headquartered Strides Pharma Science Ltd said of having US Food & Drugs Administration’s approval to launch Potassium Chloride Extended-Release Tablets in the US market. The medicine is used to prevent or to treat low blood levels
USFDA inspects Pithampur facility of Unichem Labs, makes 4 observations
MUMBAI | RAJKOT – In a regulatory filing submitted to the Exchanges in India on Wednesday, Unichem Laboratories Ltd said of the Company’s API manufacturing facility at Pithampur, Madhya was inspected by US FDA from July 23rd to July 27th, 2018. The regulatory body made four (4) observations during the aforementioned inspection period. However, the company