Tag Archives: US Food and Drugs Administration

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 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

Zydus Cadila gets USFDA nod to market anti-bacterial drug to cure respiratory, skin, ear and sexually transmitted disease

AHMEDABAD | MUMBAI | RAJKOT – Zydus Cadila (Cadila Healthcare Ltd) has received the final approval from the USFDA to market Azithromycin for Oral Suspension USP (US RLD – Zithromax), 100 mg/5 mL and 200 mg/5 mL, the company said in the press release submitted to Exchanges in India on Wednesday. This medication contains Azithromycin, a

Zydus Cadila gets USFDA nod to market impotence treatment drug

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the exchanges in India, Cadila Healthcare Ltd said of having got tentative approval to market drug to cure erectile dysfunction. Zydus Cadila has received the tentative approval from the USFDA to market Vardenafil Hydrochloride Tablets (US RLD-Levitra) in the strengths of 2.5 mg, 5

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