Tag Archives: USFDA

#DLGGujaratConnect | VIAGRA Manufacturer – “Pfizer” shuts Aurangabad & Chennai units in India, impacting 1,700 jobs

MUMBAI | AURANGABAD | CHENNAI | NEW DELHI | AHMEDABAD | RAJKOT –  Following a thorough evaluation of the Aurangabad (Maharashtra) and Irungattukottai (Tamilnadu) plant, Pfizer Ltd has finally decided to shutdown the two facilities in India, on grounds of long-term loss of product demand, making manufacturing at this sites “unviable”, the three page handout

Zydus Cadila gets USFDA nod to market drug to treat excess iron levels in human blood

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Exchanges on Tuesday, Ahmedabad headquartered and Pankaj Patel owned Cadila Healthcare (Zydus Cadila Group) said of having got US Food and Drugs Administration nod to market drug to treat excess iron levels in human blood. Zydus Cadila has received the tentative

Alembic Pharma gets USFDA nod to market erectile dysfunction treatment drug

VADODARA (BARODA) | MUMBAI | RAJKOT – In a press release submitted to the Exchanges in India on Tuesday, Alembic Pharma said of having got approval from US Food & Drugs Administration to market erectile dysfunction treatment tablets, the product has an estimated market-size of US $ 8 million over period of 12 months. Alembic

US FDA issues form 483 to Alembic Pharma’s Panelav facility for oral solids

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update filed to the Indian Bourses on Friday, Alembic Pharmaceuticals Ltd said of having got their Panelav facility manufacturing general oral solids inspected by US FDA (Food & Drugs Administration) and the regulator having slammed Form 483 to the facility, after inspection. The United States

Zydus Cadila gets US FDA nod to market drug for treatment of epilepsy

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Tuesday, Cadila Healthcare Ltd (Dr Pankaj Patel owned Zydus Cadila group) said of having availed regulatory approval from US Food and Drugs Administration (USFDA) to market drug to treat epilepsy. Zydus Cadila has received the final approval from the

USFDA successfully inspects Alembic’s JV facility Aleor Derma

VADODARA (BARODA) | MUMBAI | RAJKOT – In a press release submitted to the Exchanges in India on Monday, in wee hours before the trading session kicked-off on the Indian Bourses, Alembic Pharmaceuticals Ltd said of Aleor Dermaceuticals Ltd’s facility, getting successfully inspected by USFDA. Aleor Dermaceuticals Ltd. (Aleor), a 60:40 Joint Venture between Alembic

Zydus Cadila gets US FDA nod to market anti-arthritis drug

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses on Thursday, Ahmedabad headquartered and Dr Pankaj Patel led Cadila Healthcare Ltd (Zydus Cadila Group) said of having received regulatory approvals from US FDA (Food & Drugs Department) to market anti-arthritis drug. Zydus Cadila has received the tentative approval from

Alembic gets US FDA nod to market diet-exercise equivalent pill, for diabetics

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted on Tuesday, Vadodara headquartered and Amin family owned Alembic Pharma said of having got approval from US FDA (Food & Drugs Administration) to market diet and exercise equivalent pill for diabetic patients. Alembic Pharmaceuticals Limited today announced that the company has received tentative

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

Zydus Cadila gets US FDA nod to market osteoporosis, ortho treatment drug

MUMBAI | AHMEDABAD | RAJKOT – Dr Pankaj Patel led and Ahmedabad headquartered Zydus Cadila Group (Cadila Healthcare Ltd) has received final approval from the US regulators to market ortho treatment medicine, the company said in a press release submitted to the Indian Bourses, today. Zydus Cadila has received the final approval from the USFDA

Zydus Cadila gets US FDA nod to market tablets for diabetic care

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Tuesday, Dr Pankaj Patel led Zydus Cadila group (Cadila Healthcare Ltd.) said of having got approval from US FDA (Food & Drugs Administration) to market Sitagliptin Tablets in dosage value of 25 mg (milligram), 50 mg and 100 mg.

Zydus Cadila gets USFDA nod to market anti-viral drug

AHMEDABAD | MUMBAI | RAJKOT – Dr Pankaj Patel led Zydus Cadila Group got US FDA (Food and Drugs Administration) nod to market anti-viral drug Acyclovir Sodium Injection in composition of 500 mg and 1,000 mg, Cadila Healthcare Ltd said today, in a press release submitted to the Exchanges in India. Zydus Cadila has received

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

Alembic Pharma gets USFDA nod to market eye-care product, company is fighting litigation over same product in US Court

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted to the Exchanges in India, Vadodara Headquartered and Amin family owned 100 years old pharma company – Alembic Pharmaceuticals Ltd said of having got nod from US FDA (Food & Drug Administration) to market eye-drops. Today, the Company today announced that they have

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