The central government has denied that it has promised to set up an AIIMS (All India Institute of Medical Sciences) in Kerala, the country’s most lucrative medical market. Asked whether the Government in 2015 had promised to set up an All India Institute of Medical Sciences (AIIMS) in the State of Kerala, union minister for […]
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 IQVIA. Metformin hydrochloride is sold in the US by Santarus Inc under the […]
Zydus Cadila said it received the final approval from the USFDA to sell Spironolactone Tablets, used to treat blood pressure and heart failure. The tablets, in strengths of 25 mg, 50 mg and 100 mg, will be used for lowering high blood pressure to prevent strokes, heart attacks and kidney problems. It is also used […]
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 Welchol. Welchol had annual sales of approximately $73.0 million for […]
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 in the UK market. This is not the first such […]
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 mln in the preceding year and 83 mln in the […]
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 approval means that the company has to wait for all […]
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 sales of approximately $191 M, according to IQVIA. The drug […]
Zydus Cadila, one of India’s largest drug makers, said it has received tentative approval to market tadalafil, the generic ingredient of the most popular erectile dysfunction drug Cialis, in the US market. The drug will be manufactured at the group’s facility at Moraiya, Ahmedabad. The USFDA approval comes weeks before Cialis is expected to lose patent […]
Glenmark Pharmaceuticals received a boost for its plans to manufacture drugs within the US, with the FDA approving the first generic manufacturing application from the facility. The FDA approved the manufacturing of Atovaquone and Proguanil Hydrochloride Tablets at its Monroe, North Carolina facility via a supplementary ANDA (drug application). “This approval is an important milestone for our […]
Indian Pharma major Lupin said it has signed an agreement with Japan-based generics maker Nichi-Iko to market its upcoming biosimilar drug, Etanercept, in the far eastern nation. Etanercept, already approved in the US, is used to treat inflammatory conditions. It is pending approval in Japan and Europe. According to Lupin, the non-US market for Etanercept […]
Alembic Pharmaceuticals said the USFDA has permitted it to sell antibiotic doxycycline in the US market. Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, are considered a medium sized drug from a market perspective and had sales of US$ 80 million in 2017, according to IQVIA. It is sold by Pfizer under thebrand Vibramycin. […]
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 was expected to take 6-8 months, however, due to reasons […]
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 past. The Chinese patent has the number CN105814020 and the American […]
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 be taken multiple times a day — basal insulin releases […]
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 at an SEZ in the city, was conducted between May […]
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 group and IHH Healthcare of Malaysia. Interestingly, the company had […]
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 to the close of Rs 423 yesterday, before making up […]
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 manufacturing facility at Ahmedabad. Capsule Omeprazoleand Sodium Bicarbonate is used […]
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, as per IQVIA, the company said. The launch of the […]
