Tag Archives: US Food & Drugs Administration

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