Tag Archives: USFDA

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

Alembic Pharma gets USFDA nod to market drug to treat epilepsy & seizures

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges today, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having received receives USFDA Approval for Clonazepam Orally Disintegrating Tablets USP, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg. The press release submitted by

Alembic Pharma gets USFDA nod to market drug to treat influenza

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR-RAJKOT – In a press release submitted to the Indian Bourses, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having got approval from US Food & Drugs Administration (USFDA) to market drug to treat influenza. The press release submitted to the Indian Stock Exchanges read where the company said, Alembic

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

USFDA inspects Lupin Pharma’s Mumbai facility, slam 4 observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – USFDA (US Food & Drugs Administration) inspected the Mumbai facility of Lupin Pharma and has issued Establishment Inspection Report to the site & facility inspected.  The Regulators have also slammed 4 observations post inspecting the Lupin’s Mumbai facility In a regulatory filing submitted to the Indian Exchanges,  Pharma major

Zydus Cadila gets USFDA nod to market high blood-pressure treatment drug

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Stock Exchanges in India on Monday, Ahmedabad headquartered Zydus Cadila Group (Cadila Healthcare) said of having received the final approval from the USFDA (United States Food & Drugs Administration) to market Chlorthalidone Tablets USP (US RLD – THALITONE@),25 mg and 50 mg.

USFDA slams “certain observations” after inspecting Torrent Pharma’s Indrad facility

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a regulatory update filing submitted to the Indian Bourses, Ahmedabad located pharma company  Torrent Pharmaceuticals Ltd said, inspection at Indrad Plant of the Company was carried out by US FDA in the month of April, 2019. The company has received certain observations which are procedural in nature and

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

Wockhardt’s Bioequivalence Centre @ Aurangabad inspected by USFDA, no observations

AURANGABAD | MUMBAI | RAJKOT – In a regulatory update filing submitted to the Indian Bourses on Monday, India Pharma major Wockhardt Ltd said of  US Food and Drug Administration (USFDA) carried out inspection of Bioequivalence Centre located at R&D Centre, Aurangabad during which Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg ER

Sun Pharma Launches Ready-to-Infuse INFUGEM injection for cancer treatment

PRINCETON (NEW JERSEY, US) | VADODARA | MUMBAI | RAJKOT – In a press-release submitted to the Indian Exchanges on Monday, Indian Pharma sector major Sun Pharmaceutical Industries Ltd. today announced that INFUGEM™ (gemcitabine in sodium chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first chemotherapy product that comes