AYUSH Ministry hits back over criticism of Coronavirus advisory

The ministry of traditional medicines at Government of India has hit back at critics who have questioned the medical validity of its recent advisory on countering Coronavirus through herbal medicine. The AYUSH ministry had issued a list of dos and don’ts last week, including items such as ensuring proper personal hygiene, wearing face masks in […]

Zydus Cadila announces Phase-III trials of anemia drug Desidustat

Pharmaceutical manufacturer Zydus Cadila announced phase-III trials of the Desidustat, an investigational new drug and a Hypoxia-Inducible Factor (HIF) Prolyl Hydroxylase (PH) enzyme inhibitor used for the treatment of anemia and chronic kidney disease. HIF-PH inhibitors are a new class of agents for the treatment of anemia in chronic kidney disease patients. Chronic Kidney Disease […]

Govt of India starts crack down on low-quality medicine makers

The government of India has started conducting inspections at drug manufacturing units across the country to prevent the production of low-quality drugs and medicines in India. Typically, inspections are conducted by state authorities, while central agencies largely confine themselves to checking quality of final products put up on store shelves. However, in the last few […]

Shilpa Medicare receives USFDA approval for generic bone marrow drug

Shilpa Medicare Ltd said it received an approval from the United states Food & Drug Administration for Azacitidine injection. Azacitidine is used to treat myelodysplastic syndrome – a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells. The approval was received under […]

FDA observations ‘primarily procedural’ –

USFDA issued four observations about Cipla’s manufacturing facilities in Goa after conducting an audit, the company said. Cipla has three facilities in Goa. “The observations were primarily procedural in nature and the company has already responded to these observations,” said the pharma company. Further details were not given. The company said it will continue to operate their […]

Lupin receives FDA approval for generic Namenda XR dementia capsules

Pharma Major Lupin Ltd said it received final approval from United States Food and Drug Administration for selling Memantine Hydrochloride extended-release capsules, a generic version of Allergan’s Namenda XR capsules. Namenda XR extended-release capsules are approved by the USFDA for the treatment of moderate to severe dementia of the Alzheimer’s disease. It does not cure […]

Suven Life Sciences gets two product patents in India and Japan

Drug manufacturer Suven Life Sciences Ltd said it got two product patents in India and Japan for to a new compound for the treatment of disorders associated with Neurodegenerative diseases. The patents are valid through 2026-2032. The granted claims include a class of selective 5-HT6 compounds and H3 inverse agonist compounds and are being developed as […]

Marksans Pharma gets USFDA approval for sale of anti-allergy drug

Marksans Pharma Limited, an Indian pharmaceutical company, said it has received approval from the USFDA for the sale sale of its Loratadine Liquid Filled Capsules 10 mg in the US market. Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body and is used to treat sneezing, runny nose, watery […]

Lincoln Pharma develops oral spray version of Ondansetron anti-nausea drug

Lincoln Pharmaceuticals Ltd said it developed and launched an oral spray version of Ondansetron anti-nausea drug. Ondansetron is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy), radiation therapy and also in the prevention and treatment for nausea and vomiting after surgery. The medication is also more helpful during motion sickness. Presently […]

Aurobindo Pharma to launch HIV drug in Africa this year, gets tentative FDA nod

Aurobindo Pharma Limited, a pharmaceutical manufacturing company based in Hyderabad, said it received a tentative approval for HIV drug Dolutegravir from US Food & Drug Administration. It is the first FDA approval of a generic version of Dolutegravir. Through a tie up with ViiV and the Clinton Health Access Initiative, Inc., the product is expected […]

Opto Circuits subsidiary enters global market with Freeway coated shunt baloon catheter

Opto Circuits, a medical technology group, said its wholly owned subsidiary, Eurocor GmbH, entered the global market with their Freeway coated shunt baloon catheter. Freeway coated shuntbaloon catheter is used for arteriovenous (AV) access to help patients with end-stage renal disease. It also helps to reduce re-intervention and preserves future treatment options. Following the 1st […]

Suven Life Sciences granted patents in Canada, Europe & Hong Kong

Drug manufacturer Suven Life Sciences Ltd said it got three product patents from Canada, Europe & Hong Kong corresponding to new chemical entity for the treatment of disorders associated with Neurodegenerative diseases. The patents are valid through 2030-2032. According to the U.S. Food and Drug Administration, a new chemical entity (NCE) is a drug that […]

Lupin receives tentative approval for generic Rapaflo capsules

Pharma Major Lupin Limited (Lupin) announced that it received tentative approval from the United States Food and Drug Administration (FDA) for selling Silodosin capsules, a generic version of Allergan Sales’ Rapaflo capsules. Silodosin capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia, or the enlargement of tissue due to […]

Glenmark Pharma discovers potential new anti-cancer drug

Glenmark Pharmaceuticals said its overseas subsidiary has discovered a molecule that can potentially be used in targeting even difficult-to-treat lung cancer and colorectal cancer. The GBR 1372 molecule was discovered in the pharma company’s Swiss laboratory and that the company plans to file an application with the US Food and Drug Administration to approve the […]

Lupin receives tentative approval for generic Avelox tablets

Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals received a tentative approval from the US FDA for selling Moxifloxacin hydrochloride tablets, a generic version of Bayer Healthcare Pharmaceuticals’ Avelox tablets. Lupin’s Moxifloxacin hydrochloride tablets are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.’s Avelox Tablets and can be substituted by […]

Lupin receives tentative approval for generic version of Pfizer’s Zithromax

Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals LLC., received tentative approval for selling a generic version of Pfizer Inc.’s Zithromax oral suspension from the US FDA. Lupin had earlier received final approval for its Azithromycin Tablets and Azithromycin for Oral Suspension, filed from its Goa plant. Azithromycin per bottle are the […]

US FDA updates warning against widespread use of fluoroquinolones

The US Food & Drug Administration issued a warning against casual usage of fluoroquinolone antibiotics, arguably the most widely used broad-spectrum antibiotic in India. USFDA advised that the side effects caused by the use of fluoroquinolone antibacterial drugs would outweigh the benefits for patients who have alternative treatment options. Patients with acute sinusitis, acute bronchitis and uncomplicated urinary […]

CII advices caution in implementing Preferential Market Access for medical equipment

The Confederation of Indian Industry (CII), India’s biggest association of companies, has urged the government of India not to implement a Preferential Market Access for medical equipment without first setting the groundwork for promoting a components and ancillary industry in the country. It said that merely mandating local sourcing norms without helping the local industry […]