Syngene COO steps down to explore “startup opportunity”

Syngene COO steps down to explore “startup opportunity”

2018-09-28T13:14:18+00:00 On

Syngene International Ltd, the contract research unit of Biocon, announced the resignation of its chief operating officer Manoj Nerurkar. It said Nerurkar, who has been with the COO of the company for nine years, will step down to an advisory role from…

Biocon’s Bangalore plant passes USFDA inspection without incident

Biocon’s Bangalore plant passes USFDA inspection without incident

2018-09-22T11:07:28+00:00 On

Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks. “The US FDA conducted a periodic cGMP inspection of our Drug Substance manufacturing site at Bangalore Campus from Sep…

Aurobindo wins South African approval for HIV drug

Aurobindo wins South African approval for HIV drug

2018-09-18T10:37:45+00:00 On

Aurobindo Pharma said it received approval from the South African authorities to launch a key anti-HIV drug in the country, following the launch of the medicine in Sub-Saharan Africa. Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets are the  first-line, preferred regimen…

Sun Pharma gets US FDA okay for eye drug

Sun Pharma gets US FDA okay for eye drug

2018-09-14T07:54:21+00:00 On

Sun Pharmaceutical Industries said it has got US Food and Drug Administration  approval for a new eye drug that will be used for lowering intraocular pressure or IOP  in patients with open-angle glaucoma or ocular hypertension. The medicine, latanoprost ophthalmic emulsion, was developed by…

Zydus Cadila gets USFDA approval for cholesterol, psychosis drugs

Zydus Cadila gets USFDA approval for cholesterol, psychosis drugs

2018-08-30T12:49:41+00:00 On

Zydus Cadila said it received the final approval from the USFDA to market cholesterol-lowering Gemfibrozil and antipsychotic Aripiprazole in the US. Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. It is…

Lupin launches Clobetasol Propionate corticosteroid cream in US

Lupin launches Clobetasol Propionate corticosteroid cream in US

2018-08-21T15:53:54+00:00 On

Pharma major Lupin said it has launched corticosteroid cream Clobetasol Propionate in the US. The cream is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate. Clobetasol Propionate Cream USP 0.05% had annual sales of approximately USD 108.6 million in the US. It is…

Sun Pharma reports strong Apr-Jun numbers, boosted by US, India growth

Sun Pharma reports strong Apr-Jun numbers, boosted by US, India growth

2018-08-14T15:36:16+00:00 On

India’s biggest drug maker Sun Pharmaceutical Industries reported strong numbers for the first quarter of Apr-Jun this year, with rising sales lifting margins and profits. Overall sales rose 16% on year to Rs. 7,139 crores, led by growth in key geographies such…

Alembic Pharma gets tentative generic nod for Allergan’s Latisse

Alembic Pharma gets tentative generic nod for Allergan’s Latisse

2018-08-06T11:36:17+00:00 On

Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration for launching a therapeutic equivalent of Latisse ophthalmic solution. Allergan Bimatoprost solution is used to treat loss of hair, or hypotrichosis, of the eyelashes. The solution, with an…

1,104 people die during clinical trials in India in 3 years

1,104 people die during clinical trials in India in 3 years

2018-08-06T08:46:08+00:00 On

A total of 1,104 people have died during clinical trials of various drugs and procedures in India in the last three years, according to the ministry of health and family welfare. However, not everyone who died during clinical trials are found to…

Sun Pharma launches diabetes drug metformin in the US

Sun Pharma launches diabetes drug metformin in the US

2018-07-25T13:19:21+00:00 On

Sun Pharmaceutical Industries  said it has launched the glucose regulating drug  metformin hydrochloride in the United States. The tablets in two strengths — 500 mg and 1000 mg —  have an addressable market size  of around $443 million, the company said, quoting…

Glenmark Pharma gets USFDA approval for generic cholesterol drug

Glenmark Pharma gets USFDA approval for generic cholesterol drug

2018-07-17T09:16:25+00:00 On

Glenmark Pharmaceuticals said received approval from the United States Food & Drug Administration to sell cholesterol-lowering drug Colesevelam Hydrochloride in the country. The approval is for two packet sizes – 1.875 grams and 3.75 grams. Colesevelam Hydrochloride is the generic version of Daiichi…

Lupin’s Goa plant completes successful inspection by UK MHRA

Lupin’s Goa plant completes successful inspection by UK MHRA

2018-07-16T11:31:19+00:00 On

Pharma major Lupin said its Goa facility has successfully completed an inspection by the UK Medicines and Healthcare Products Regulatory Authority. “There were no critical or major observations in the inspection,” it said, indicating that products made at the facility can continue…

Zydus Cadila gets tentative US approval for iron excess drug

Zydus Cadila gets tentative US approval for iron excess drug

2018-07-07T12:30:56+00:00 On

Zydus Cadila said it has received tentative regulatory approval from the US Food & Drug Administration for selling Deferasirox, used to chelate or expel excess iron from the blood. The drug is sold under names such as Exjade, Desirox, Defrijet, Desifer, Rasiroxpine…

Cipla wins approval for generic testosterone in the US

Cipla wins approval for generic testosterone in the US

2018-06-21T09:47:03+00:00 On

Drug maker Cipla said it received final approval for selling a generic testosterone injection in the US. Cipla’s Testosterone Cypionate Injection 100mg /ml and 200mg /ml is an AO-rated generic equivalent version of Pharmacia and Upjohn’s Depo-Testosterone. Depo-Testosterone and its generic equivalents…