Tag Archives: ANDA

Dr. Reddy’s Labs gets USFDA nod to market insomnia treatment drug

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Bourses, Hyderabad based Indian pharma major Dr. Reddy’s Laboratories Ltd said of having got US FDA (Food & Drugs Administration) nod to market drug to treat insomnia (troubles having to fall asleep). The press release submitted to the Indian Stock

Laurus Labs’ exclusive distribution partner gets USFDA nod to market neuropathy treatment drugs

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Hyderabad headquartered Laurus Labs said of its exclusive distribution partner in US getting rights from US FDA (Food & Drugs Administration) to market neuropathy treatment drug. The press release submitted by the company to the Indian Bourses

Alembic Pharma gets USFDA nod to market neuropathic treatment drug

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Vadodara (Baroda) Gujarat based pharma major Alembic Pharmaceuticals Ltd said of having received nod from US FDA (Food & Drugs Administration) to market neuropathic & diabetic treatment drug. In the press release submitted to the Indian

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

Alembic Pharma gets USFDA nod to market drug to treat influenza

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR-RAJKOT – In a press release submitted to the Indian Bourses, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having got approval from US Food & Drugs Administration (USFDA) to market drug to treat influenza. The press release submitted to the Indian Stock Exchanges read where the company said, Alembic

Zydus Cadila (Healthcare) gets USFDA nod to market anti-epileptic drug to prevent & control seizures

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses on Monday, Ahmedabad headquartered pharma major – Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) has received the tentative approval from the USFDA to market Lacosamide Tablets (US RLD – Vimpat®) in the strengths of 50 mg, 100 mg,

Caplin Point inks pact with Baxter for generic injectables

CHENNAI | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – Chennai headquartered Caplin Point Laboratories Limited  announced that Caplin Steriles Limited (a Wholly Owned Subsidiary of Caplin Point Laboratories Ltd) has entered into a license and supply agreement with Baxter Healthcare Corporation for five generic injectable ANDAs. For more details, please click the link, given here : https://buff.ly/2TZ8mIg

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

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

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

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

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