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