Dr. Reddy’s Laboratories launches heart drug in the US

Pharma company Dr. Reddy’s Laboratories Ltd said it launched Nitroglycerin sublingual tablets — a therapeutic equivalent generic version of Nitrostat sublingual tablets — in the US market. The medication is used before physical activities (such as exercise, sexual activity) to prevent chest pain (angina) in people with a certain heart condition (coronary artery disease). It may […]

Lupin receives tentative US FDA approval for generic version of Paxil

Indian pharma major Lupin Ltd announced today that it received tentative approval from the United States Food & Drug Administration to market a generic version of Apotex Technology’s ‘Paxil’ Paroxetine tablets. The medicine is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder. Tentative FDA approvals do not […]

EMA accepts review for Mylan and biocon’s trastuzumab biosimilar

Mylan N.V. and Biocon Ltd. said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar version of biosimilar Trastuzumab, a medicine used to treat breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Mylan’s MAA for […]

Stride Shasun receives USFDA approval for constipation treatment

Pharma company Strides Shasun announced that it received the United States Food & Drug Administration (USFDA) approval for Polyethylene Glycol powder to treat occasional constipation. The powder when consumed as a solution works by softening the stool and increasing the frequency of bowel movement by retaining water in the stool, added the company. Yeterday the […]

USFDA issues establishment inspection report for NATCO Pharma’s Chennai plant

NATCO pharma, a Hyderabad based pharmaceutical company, said it received establishment inspection report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted during the period February 8 – February 12 at its Chemical Division in Chennai. Earlier in mid-August, US FDA had issued an establishment inspection report to Natco Pharma’s for […]

Ayush ministry signs MOU with US Pharmacopeial to strengthen traditional medicine

Ministry of Ayush, government of India signed a memorandum of understanding (MOU) with United States Pharmacopeial Convention for cooperation in the field of traditional medicine. The aim is to promote the safety, quality and integrity of traditional medicines and botanical dietary supplements, the government said. The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization […]

AstraZeneca Pfizer deal to hit Indian unit due to the loss of Meronem

AstraZeneca Pharma India said AstraZeneca UK has asked to terminate its existing distribution arrangements for Meronem (meropenem) in India. “This is as a result of a global agreement by AstraZeneca PLC to sell the development and commercialisation rights to Pfizer Inc, of its late-stage small molecule antibiotics business,” the company said. Separately, its global parent […]

Stride Shasun receives USFDA Approval for Ranitidine Tablets

Pharma company Strides Shasun announced that it received the United States Food & Drug Administration (USFDA) approval for generic Ranitidine Tablets, used to treat and prevent ulcers in the stomach and intestines. Ranitidine tablet is the first integrated product approval post merger of Strides and Shasun in 2015. The active ingredient and formulations will be […]

Lupin gets approval for new indigestion tablets in India

Lupin Ltd announced today that it has received approval to launch Acotiamide 100 mg indigestion tablets in India from the Central Drugs Standard Control Organization. Acotiamide is a drug to be introduced into the Indian Pharmaceutical Market which could benefit millions of patients suffering from Dyspepsia or Indigestion, most common stomach complaints encountered in clinical […]

Cadila Healthcare says US FDA closes inspection of Ahmedabad ointment plant

Cadila Healthcare said that US FDA has successfully closed an inspection at its facility at Changodar at Ahmedabad. The inspection was carried out in March 2016. The plant makes ointments and is not part of Moraiya formulations manufacturing plant, it said. The receipt of Establishment Inspection Report (EIR) “indicates the successful closure of the inspection […]

Cadila Healthcare acquires gall bladder drug from Albert David

Zydus Healthcare Limited, a wholly owned subsidiary of Cadila Healthcare said it has entered into a definitive agreement to acquire ‘Actibile’ from Albert David Limited. No pricing was disclosed. The gastroenterology drug is used for dissolving gall bladder Stones. The deal will be financed through internal accruals, the pharmaceutical company said. “The gastrointestinal segment has […]