After EU, Lincoln Pharma gets Australian approval for plant

India-based Lincoln Pharmaceuticals Ltd said it is looking forward to entering the Australian market, after Australia’s medicines and medical devices regulator – Therapeutic Goods Administration {TGA) – approved the company’s primary manufacturing plant in Khatraj, Gujarat. The approval, said the medicine manufacturer, has been granted for all three sections, tablets, capsules and creams & ointments. […]

Biocon launches cancer medicine in the US

Biopharmaceuticals manufacturer Biocon Ltd launched cancer medication Everolimus tablets in the US. The formulation, a generic version of Afinitor from Novartis, is a prescription medication that is used to treat certain types of cancers and tumours. The tablet has annual sales of around $675 mln in the US, which makes it among the larger drugs […]

Zydus Cadila signs deal with Shipa Medicare for ZyCoV-D production

Cadila Healthcare, also known as Zydus Cadila, has taken one more step towards augmenting the production capacity for its DNA-based Covid vaccine known as ZyCoV-D by inking an agreement with Shilpa Medicare. Under the agreement, Shilpa Medicare Ltd will use its biologics manufacturing plant at Dharwad, Karnataka, to manufacture ZyCoV-D. ZyCoV-D is the world’s first […]

Zydus Cadila gets US-FDA nod for antidepressant drug

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 […]

Lupin gets license to manufacture new TB drug

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 […]

Alkem’s Taloja test facility passes US FDA inspection

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 […]

Glenmark, Cipla get US nod for inhaler drug

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 gets US FDA warning letter for Somerset plant

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 […]

Wockhardt says in talks with COVID-19 vaccine makers

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 annuls diabetes drug deal with Abbott Healthcare

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 rejigs diabetes drug deal with Sun Pharma

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 launches affordable breast cancer drug in India

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. […]

Natco Pharma starts Ph III trial of new COVID drug molnupiravir

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 caps strong year with Q4 growth

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 […]

COVID-19: Eli Lilly lets Torrent Pharma manufacture Bartinicib

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 […]

Dr Reddy’s gets nod to start supplying Sputnik V

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 gets nod for injectables unit merger

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, […]

Biocon, Lupin launch new drugs in USA

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 […]