Tag Archives: Establishment Inspection Report

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

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

Wockhardt’s Shendra (Aurangabad) facility gets inspected by EU Regulators

MUMBAI | RAJKOT – In a regulatory update filed to the Indian Stock Exchanges, Wockhardt Ltd said of European Regulators having successfully inspected Shendra (Aurangabad) facility of the company and granting needed licenses for manufacturing medicines from inspected facility. For more details, click the link, given here : https://buff.ly/2HZ5fNU  Follow DATELINE GUJARAT On :-Facebook, Google+, Linkedin, Twitter, YouTube SHARE THIS NEWS ON

USFDA inspects Strides Pharma’s Bengaluru facility, gets EIR with Zero 483 Observations

BANGALURU | MUMBAI | RAJKOT – US FDA (Food & Drugs Administration) successfully inspected Strides Pharma Sciences Ltd’s formulations facility (KRSG Gardens) in  Bengaluru and the facility has  received the Establishment Inspection Report (EIR), there by confirming the successful  closure of the inspections, the company said in Press Release submitted to the Indian Stock Exchanges

Zydus Biologics (of Zydus Cadila Group) inspected successfully by US FDA

AHMEDABAD | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses, Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) said of one of the company’s subsidiary facilities being inspected successfully by US Food & Drug Administration. The Company’s Biologics manufacturing facility (Zydus Biologics) located at the Zydus Biotech Park in

Sun Pharma gets USFDA nod to market eye-drops for dry-eye illness

VADODARA (BARODA) | MUMBAI | RAJKOT – Sun Pharma has got US FDA (Food & Drugs Administration) nod to sell eyedrops (opthalmic solution) to increase tear-production in patients with dry eye, the company said in a press release submitted to the exchanges in India. Sun Pharmaceutical Industries Ltd. today announced that Sun Pharma has received

Sun Pharma launches Sprinkler version of medicine in US, to cure blood-pressure, chest-pain, heart-failure disorders

VADODARA (BARODA) | MUMBAI | RAJKOT – Vadodara headquartered and Sanghvi family owned Sun Pharma today announced launch of sprinkle version of medicine which can sprinkled on food and consumed by patients to cure blood pressure, chestpain and heart-failure disorders. According to the press release submitted by the company to the exchanges in India, this

Subsidiary of Sun Pharma launches oral diabetic care treatment drug in US

VADODARA (BARODA) | MUMBAI | RAJKOT – Sun Pharmaceutical Industries Ltd., today announced that one of its wholly owned subsidiaries has launched the generic  versions of Glumetza® (metformin hydrochloride) extended release tablets, 500 mg and 1000 mg in the US. Metformin is an oral diabetes medicine that helps control blood sugar levels. These generic Metformin HCl extended release

Alkem Lab’s Daman (Amaliya) Unit gets Establishment Inspection Report from USFDA

MUMBAI | DAMAN | RAJKOT – Alkem Laboratories Ltd in a regulatory filing said of having availed establishment inspection report (EIR) from US FDA (Food & Drug Administration). US FDA has issued an Establishment Inspection Report (EIR) for the Company’s manufacturing facility located at Amaliya, Daman, India which was inspected from 19th March, 2018 to

Sun Pharma responds to Bourse queries, awaits Halol facility’s Inspection report

VADODARA | MUMBAI | RAJKOT – Sanghvi family owned and Vadodara headquartered Sun Pharmaceuticals Industries Ltd has informed the exchanges in India of the company awaiting US Food and Drug Administration’s report on Halol facility inspection, the company said in filing to the exchanges in India, today which was in form of written response to