Tag Archives: USFDA

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

Cipla’s Goa units gets EIR after being inspected by USFDA

MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, pharma major Cipla Ltd said United States Food and Drug Administration (USFDA) at the Goa manufacturing facility from 21st – 28th January, 2019, the Company has received the Establishment Inspection Report (EIR), indicating closure of the inspection. For more details, please click the

USFDA concludes Cadila Healthcare’s (Zydus) Pharmez facility with one observation

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, on Wednesday, Ahmedabad headquartered Pharma major Cadila Healthcare (Dr Pankaj Patel led Zydus Cadila Group) Ltd said of one of their units being inspected by US Food & Drugs Administration (USFDA) and the regulator has concluded the inspection with one

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 cleared the Goa based sterile mfg site of Indoco Remedies

MUMBAI | RAJKOT – In a regulatory update submitted to the Stock Exchanges in India, Indoco Remedies Ltd said of US Food an Drug Administration (USFDA), having cleared the sterile manufacturing facility of the company, for Finished Dosages, located at Verna Industrial Area, Goa (Plant II). This i an outcome of the recent inspection conducted

Zydus Cadila gets USFDA nod, to market tablets, to treat high blood-pressure in lungs

AHMEDABAD | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses, Ahmedabad headquartered pharma major – Cadila Healthcare Ltd (Dr Pankaj Patel owned Zydus Cadila Group) said of having received final approval from the US Food & Drugs Administration (USFDA) for Ambrisentan Tablets. The Company has received the final approval from the

Lupin gets USFDA nod to market tabs to cure erectile dysfunction

MUMBAI | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Pharma major Lupin Limited (Lupin) announced that it has received approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Eli

USFDA approves Strides Pharma’s Singapore based oral dosage facility

BENGALURU | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Wednesday, Strides Pharma Science Ltd said of the Company having received USFDA approval for its  greenfield oral dosage facility in Singapore.  The company has further said that Singapore facility aims to provide growth capacities for regulated markets of US,

USFDA inspects Zydus Cadila’s subsidiary co, issues one observation

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses, Ahmedabad headquartered Cadila Healthcare Ltd said of its USFDA conducted a Pre-Approval Inspection (PAI) for Doxorubicin Liposomal, a complex oncological injectable at Alidac Pharmaceuticals Ltd., the injectable onco manufacturing facility, located at Pharmez, Ahmedabad from 18th to 26th March, 2019.

Dr Reddy’s Lab gets USFDA nod to market erectile dysfunction treatment tabs in US

HYDERABAD | MUMBAI | RAJKOT –  In a press release submitted to the Indian Bourses, Dr Reddy’s Laboratories Ltd today announced the launch of Tadalafil Tablets USP, a therapeutic equivalent generic version of Cialis (tadalafil) Tablets in the United States market, approved by the U.S. Food and Drug Administration (USFDA). For more details, please click