Zydus Cadila said it received approval from the US Food & Drug Administration to sell new generation anti-depressant Vortioxetine in the US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Around 2007, Japanese pharmaceuticals maker Takeda agreed to pay an upfront […]
Indian pharmaceuticals manufacturer Lupin Ltd said it received a non-exclusive license to manufacture the anti-TB drug pretomanid from non-profit drug developer, TB Alliance. The company said it plans to sell the drug in 140 countries and territories, including many of the highest TB burden countries around the world. Pretomanid will be administered as part of […]
Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks. “US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of […]
Sun Pharma, one of India’s largest pharmaceuticals manufacturers, said it has acquired the exclusive license to sell an acne cream in the US and Canada for an upfront payment of $45 million and potential milestone payments of up to $190 mln. The rights to sell Winlevi branded clascoterone cream were acquired from Italy-based Cassiopea SpA. […]
Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana. The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for […]
Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey. “We wish to inform you that the Company has received a warning letter from the US FDA for the company’s […]
Mumbai-based pharmaceuticals manufacturer Wockhardt officially confirmed that it is indeed in negotiations with multiple companies to explore the option of manufacturing their COVID-19 vaccines. The confirmation comes in the wake of recent media reports quoting government sources that the company had suggested to the government that it can divert some of its manufacturing capacities for […]
AstraZeneca India, which entered into a licensing deal with Sun Pharma for a key diabetes drug, said that it had terminated a distribution agreement for the same drug with Abbott Healthcare. The drug, dapagliflozin, was being supplied to Abbott Healthcare by the Indian unit of the British-Swedish company under a distribution agreement, which has now […]
AstraZeneca Pharma India, the local unit of the global pharmaceuticals giant, said it has decided to end its marketing agreement with Indian pharmaceutical giant Sun Pharma for two diabetes medications after the Indian company acquired a license to manufacture the same locally. In a separate statement, Sun Pharma said it has acquired the patent license […]
Zydus Cadila, the pharmaceutical arm of the Zydus group, said it has launched a next-generation breast cancer drug in India at a fraction of its existing cost. The drug, Trastuzumab Emtansine, is considered the first targeted chemotherapy drug for breast cancer as it directs the cytotoxic activity at cancer cells by using a known biomarker. […]
Less than a month after it approved for clinical trial approval, Hyderabad-based Natco Pharma said it has begun dosing patients in its phase III clinical trial for molnupiravir, a promising candidate for treating COVID-19 that is being studied across the world. Phase III trial data can be submitted to regulatory agencies for seeking approval of […]
Aarti Drugs, one of the biggest manufacturers of ingredients for the pharmaceuticals industry in India, reported a strong performance for the fourth quarter and full year 2020-21. All three of the Mumbai-based company’s business divisions — APIs or pharmaceutical ingredients, formulations or medicines, and specialty chemicals — contributed to a strong peformance, resulting in an […]
A week after Natco Pharma sought a compulsory license from government of India to manufacture COVID treatment drug Baricitinib, the US firm holding the rights to the drug — Eli Lilly — seems to have agreed to let several companies to manufacture and sell the drug. Baricitinib is used for treating joint inflammation in rheumatoid […]
Pharmaceuticals manufacturer Dr. Reddy’s Laboratories Ltd said it received permission from India’s drug regulator to import and supply the Sputnik V COVID-19 vaccine in India. Like the other two vaccines approved in India, the nod for Sputnik V is also an ’emergency use authorization’, meaning that it cannot be sold to anyone and everyone, but […]
Gufic Lifesciences Ltd, one of the oldest pharma companies in India, today said it has won the last pending regulatory approval for the amalgamation of its injectables unit with itself. It said it won approval from National Company Law Tribunal Mumbai for the merger last week. Since the transaction has a date of Jan 1, […]
Glenmark Pharmaceuticals Ltd said it has launched a new diabetes drug in India at a price that is around 65% cheaper than those of competing offerings. The new drug is a combination of a Sodium Glucose Co-Transporter Inhibitor (SGLT2i) and a Dipeptidyl Peptidase 4 inhibitor. “Glenmark’s Remo V and Remozen V are priced at Rs. […]
Bicon Ltd and Lupin Ltd, two India-based pharmaceutical manufacturers, launched two drugs in the US, separately. Bangalore-based Biocon launched an immunosuppressant, while Lupin launched a pain relief drug. Biocon’s drug is called Tacrolimus, and it is a calcineurin inhibitor. The company said the drug is used in organ transplant patients to reduce the body’s ability […]
Pharmaceuticals manufacturer Indoco Remedies has won a major contract to supply Allopurinol, used to bring down uric acid in the blood, from Germany. The two-year contract will generate around Rs 70 cr per year for the company. “This is Indoco’s first own label product in Europe,” said Managing Director Aditi Kare Panandikar. “Germany is totally […]
Pharmaceutical manufacturer Zydus Cadila said it received permission to initiate clinical trials for ZYIL1, an oral small molecule NLRP3 inhibitor, as an anti-inflammatory agent. The molecule is being explored for treating a variety of inflammation-related conditions, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, gastro-intestinal diseases (inflammatory bowel disease), […]
Indian drugmaker Laurus Labs said it signed a definitive agreement to acquire a majority stake in a Bangalore-based, fast-growing biotech company, Richcore Lifesciences, for Rs 246.67 cr. Richcore has advanced R&D and manufacturing facilities to develop and manufacture biotech products critical for manufacturing biological drugs. Richcore also helps its global customers to develop and scale-up […]
