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 Sankyo’s oral suspension...
HEALTHCARE
Lupin’s Goa plant completes successful inspection by UK MHRA
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 to be sold...
Cipla buys South African pharma maker for Rs 225 cr
Cipla, one of India’s largest pharmaceuticals makers, said it has agreed to buy South African pharmaceuticals maker Mirren for 450 mln rand, or about Rs 225 cr. Mirren is a fast-growing OTC specialist with 152 mln rand of turnover in the last financial year, 123...
Zydus Cadila gets tentative US approval for iron excess drug
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 and Jadenu. Tentative...
Cipla wins approval for generic testosterone in the US
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 h ad US...
Zydus receives US nod for generic Cialis ahead of patent expiry
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, Ahmedabad. The USFDA...
Glenmark Pharma gets UDFDA nod for first generic out of US facility
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 a supplementary ANDA...
Lupin ties up with Japan-based Nichi-Iko for biosimilar launch
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 approval in Japan...
Alembic Pharma gets nod for doxycylcine antibiotic in the US
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 in 2017, according...
Fortis Healthcare drops plan to demerge SRL Diagnostics
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, the entire process...
Suven Life Sciences wins patents in China, USA
Suven Life Sciences said it has obtained one product patent each from China and the US related to its 5-HT4 and 5 HT6 compounds. These patents add to the similar protections won in countries such as India, Korea, Singapore, Canada, Japan and Australia in the...
Cipla to sell Eli Lilly’s Basaglar insulin in India
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 — which have to...
USFDA completes inspection at Zydus’ Ahmedabad plant
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 the plant, located...
Fortis Healthcare calls for fresh bids from all three parties
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 and Dabur, TPG-Manipal...
Strides Shasun denies rumors of auditor resignation
Pharma major Strides Shasun denied rumors that its auditors had resigned. The rumors, coming close on the heels of a similar development at Manpasand Beverages, had impacted the company’s share price today morning. Shares of Strides Shasun fell to a low of Rs 397 compared...
Zydus Cadila gets USFDA approval for ointment, ulcer capsules
Pharma giant Zydus Cadila said it received final approval from the US Food and Drug Administration to sell a skin ointment and an ulcer tablet in the country. Ointment Nystatin is used to treat fungal skin infections and will be manufactured at the group’s Topical...
Sun Pharma launches authorized version of Daiichi Sankyo’s cholesterol drug in the US
India-based Sun Pharmaceutical Industries said it has launched an authorized generic version for Daiichi Sankyo’s cholesterol drug Welchol in the US market. The drug, whose compound name is colesevelam hydrochloride, had US sales of approximately US$ 520 million for the 12 months ending March 2018,...
Suven Life Sciences wins 2 patents in Australia, 1 in Singapore
Pharma player Suven Life Sciences said it received two patents from Australia and one from Singapore for new drugs that can be used for the treatment of disorders associated with Neurodegenerative diseases. “The granted patents include the class of selective H3 Inverse agonists and 5HT...
Strides Shasun, Apotex to merge Australian ops to create biggest generics player
Pharma player Strides Shasun said it has agreed in principle to merge its Australian business with the Australian operations of peer Apotex. Both have substantial businesses in Australia; Strides under the Arrow brand and Apotex under its primary brand. The merger will enable Strides, through...
Zydus Cadila gets USFDA nod for swelling drug
Zydus Cadila, one of India’s largest pharmaceuticals manufacturers, said it got the the final approval from the US Food and Drug Administration to market Bumetanide, used to treat swelling. The drug is used for treating edema, or the swelling of legs, feet, hands or other...