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. […]

Max Healthcare wins two plots in HUDA auction, to add 1,000 beds

Max Healthcare Institute Ltd, one of India’s largest hostpital chains, said it has been allocated around 11.36 acres of land in the heart of Gurgaon city to set up two hospitals. The two plots, allocated by Haryana Shahri Vikas Pradhikaran, measure 6.11 acres and 5.26 acres. Both plots are in well populated areas of Gurgaon, […]

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 […]

Biocon Malaysia insulin aspart plant hit with 6 observations by US FDA

Six months after getting a VAI status from the US Food & Drug Administration for its insulin glargine manufacturing facility in Malaysia, Biocon — India’s largest biopharmaceuticals company — said the US FDA issued six observations after pre-approval inspections at its insulin aspart plant in that country. Insulin glargine is a long-acting insulin-substitute, while insulin […]

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 […]

Zydus Cadila gets 6-month exclusivity in US for arthritis drug

Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]

Zydus Cadila gets nod for ZyCoV-D DNA COVID vaccine

Zydus Cadila has finally said it got Emergency Use Authorization (EUA) from Indian authorities to administer ZyCoV-D — the world’s first DNA-based COVID-19 vaccine — for both adults and teenagers. This is the first time any COVID-19 vaccine has been approved for those below 18 years of age in India. The approval has been given […]

Cadila Healthcare hopes to get Zydus COVID vaccine approval in 1-2 weeks

Cadila Healthcare MD Sharvil Patel said the company has started stockpiling the ZyCoV-D COVID vaccine, and is in the process of providing additional data to drug regulators and hopes to get the shot approved in one or two weeks. If approved, ZyCoV-D will become the first vaccine anywhere in the world to use DNA to […]

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 […]

Sanofi sells India nutraceuticals unit to Kedaara-backed firm

The Indian unit of French pharmaceuticals maker Sanofi said it decided to sell its nutraceuticals business Universal Nutriscience Private Ltd for Rs 587.0 cr ($80 mln) plus debt-like obligations such as retirals and provisions for sales returns. Universal Nutriscience is a joint venture between Kedaara Capital Fund II LLP and Universal Medicare Private Limited. The […]

COVID-19: Zydus Cadila’s DNA vaccine shows 100% efficacy in teens

Indian Pharmaceutical major Zydus Cadila has become the world’s first to seek approval for a DNA-based vaccine against COVID-19, with trials indicating 100% efficacy in adolescents against moderate disease after three doses. The vaccine, which is likely to be approved by Indian authorities, also promises relief for those afraid of needles, as it can be […]

Dr Reddy’s launches 2DG Covid drug for Rs 990

Dr Reddy’s Laboratories, one of India’s largest pharmaceutical manufacturers, commercially launched 2DG COVID-19 treatment today, starting with the bigger cities. The drug, formulated by DRDO’s Institute of Nuclear Medicine & Allied Sciences in collaboration with Dr Reddy’s, is supposed to reduce the viral load in patients suffering from COVID-19. The drug, 2-deoxy-D-glucose, is supposed to […]

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 […]