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…

Zydus receives US nod for generic Cialis ahead of patent expiry

Zydus receives US nod for generic Cialis ahead of patent expiry

2018-06-19T12:47:50+00:00 On

Zydus Cadila, one of India’s largest drug makers, said it has received tentative approval to market tadalafil, the generic ingredient of the most popular erectile dysfunction drug Cialis, in the US market. The drug will be manufactured at the group’s facility at Moraiya,…

Glenmark Pharma gets UDFDA nod for first generic out of US facility

Glenmark Pharma gets UDFDA nod for first generic out of US facility

2018-06-19T09:04:12+00:00 On

Glenmark Pharmaceuticals received a boost for its plans to manufacture drugs within the US, with the FDA approving the first generic manufacturing application from the facility. The FDA approved the manufacturing of Atovaquone and Proguanil Hydrochloride Tablets at its Monroe, North Carolina facility via…

Lupin ties up with Japan-based Nichi-Iko for biosimilar launch

Lupin ties up with Japan-based Nichi-Iko for biosimilar launch

2018-06-18T11:21:47+00:00 On

Indian Pharma major Lupin said it has signed an agreement with Japan-based generics maker Nichi-Iko to market its upcoming biosimilar drug, Etanercept, in the far eastern nation. Etanercept, already approved in the US, is used to treat inflammatory conditions. It is pending…

Alembic Pharma gets nod for doxycylcine antibiotic in the US

Alembic Pharma gets nod for doxycylcine antibiotic in the US

2018-06-14T11:04:29+00:00 On

Alembic Pharmaceuticals said the USFDA has permitted it to sell antibiotic doxycycline in the US market. Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, are considered a medium sized drug from a market perspective and had sales of US$ 80 million…

Fortis Healthcare drops plan to demerge SRL Diagnostics

Fortis Healthcare drops plan to demerge SRL Diagnostics

2018-06-14T09:17:20+00:00 On

Fortis Healthcare said it has cancelled its plan to demerge and list its diagnostics arm, SRL Ltd, and will withdraw the concerned application before the authorities. “The Scheme is currently pending for approval with the National Company Law Tribunal, Chandigarh Bench. Further,…

Cipla to sell Eli Lilly’s Basaglar insulin in India

Cipla to sell Eli Lilly’s Basaglar insulin in India

2018-06-08T13:03:14+00:00 On

Indian pharmaceutical giant Cipla Ltd said it would sell Eli Lilly and Co’s insulin glargine in India. Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. Unlike regular insulin shots —…

USFDA completes inspection at Zydus’ Ahmedabad plant

USFDA completes inspection at Zydus’ Ahmedabad plant

2018-06-06T09:53:42+00:00 On

Pharmaceuticals maker Zydus Cadila said the USFDA has completed an inspection of its injectables manufacturing plant at Ahmedabad with zero observations. No observations is good news for pharma manufacturers as it indicates that the inspectors found everything to order. The inspection of…

Fortis Healthcare calls for fresh bids from all three parties

Fortis Healthcare calls for fresh bids from all three parties

2018-05-29T15:44:57+00:00 On

Fortis Healthcare Ltd said it has decided to call for fresh bids for investing into the company for a controlling stake. The move follows a messy proposals and counter-proposals by the three main bidders — a team of promoters of Hero MotoCorp…