Tag Archives: US Food Drug Administration

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

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

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

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

Zydus Cadila gets USFDA nod to market injection to cure liver injury

AHMEDABAD | MUMBAI | RAJKOT – Cadila Healthcare Ltd in a regulatory filing submitted to the Exchanges in India said of having got US FDA (Food & Drug Administration) nod to market an injection to cure liver injury. Zydus Cadila has received the final approval from the USFDA to market Acetylcysteine Injection (US RLD –

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