Zydus Pharmaceuticals

Zydus Lifesciences gets Mexican authority nod for cancer remedy biosimilar

Zydus Lifesciences Ltd on Monday said it has received marketing approval from the Mexican regulatory authority for its biosimilar product -- Bhava, used in the treatment of certain types of cancers. Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Bhava, a Bevacizumab biosimilar and it will be marketed in different strengths of 100 mg/4 ml and 400 mg/16 ml, Zydus Lifesciences said in a regulatory filing. Bhava is used in the treatment of metastatic colorectal cancer (mCRC), non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, advanced and/or metastatic renal cell carcinoma and ovarian cancer patients, it added. Zydus Managing Director, Sharvil Patel said the approval granted by COFEPRIS is the company's first biosimilars for patients in Latin America. "To bring in greater access and affordability to patients battling critical ailments, we have been developing a pipelin

Zydus gets tentative nod from USFDA for blood pressure lowering drug

Zydus Lifesciences Ltd on Friday said it has received tentative approval from the US health regulator to market Azilsartan Medoxomil and Chlorthalidone tablets, which are indicated for the treatment of high blood pressure. The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing. Azilsartan and Chlorthalidone are diuretic combination products indicated for the treatment of high blood pressure to lower blood pressure, it added. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ- II, India, the company said. Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of USD 77.9 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.

Zydus Lifesciences inks supply pact with MSN for generic cancer drug in US

Zydus Lifesciences Ltd on Friday announced an exclusive licensing and supply agreement with MSN Laboratories for generic cancer treatment drug Cabozantinib tablets, for the US market. The company's wholly-owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing and supply agreement with MSN Laboratories for Cabozantinib tablets for the US market, Zydus Lifesciences Ltd said in a regulatory filing. Cabozantinib tablet is the generic version of CABOMETYX of Exelixis. Under the agreement, MSN Laboratories will be in charge of manufacturing and supplying the generic version of CABOMETYX, following the receipt of regulatory approval, the company said. Zydus will exclusively market, distribute, and sell the product in the US market, it added. "MSN was a first sole ANDA (abbreviated new drug application) applicant for Cabozantinib tablets, to submit a substantially complete ANDA with a paragraph IV certification and therefore may be eligible for 180 days o

Lupin appoints Jeffrey Kindler, Alfonso 'Chito' Zulueta as independent dirs

Pharma major Lupin Ltd on Thursday announced appointments of ex-Pfizer Chairman and CEO, Jeffrey Kindler and Alfonso 'Chito' Zulueta as independent directors on its board. Kindler is currently the CEO of Centrexion Therapeutics, a privately-held biotechnology company, Senior Advisor to Blackstone, Operating Partner at ARTIS Ventures and Global Chair of GLG Institute, Lupin said in a regulatory filing. He brings over four decades of business experience holding leadership positions at some of the world's most recognised companies, including Pfizer, where he served as Chairman & Chief Executive Officer, as well as McDonald's Corporation and General Electric Company, the company added. Before that, he was a partner at law firm Williams & Connolly. Zulueta currently serves as Non-Executive Chairman of the board of directors of Interpharma Investments Ltd, the holding company of Zuellig Pharma, one of the largest healthcare services groups in Asia, Lupin said. He is also President ..

Zydus Lifesciences' Rs 600 crore buyback offer to open on Feb 29

Zydus Lifesciences on Tuesday said its offer to buy back 59.7 lakh shares at Rs 1,005 apiece, aggregating to Rs 600 crore, will open on February 29. The share repurchase programme will close on March 6, 2024, the drug firm said in a regulatory filing. The company proposed to buy back up to 59,70,149 shares at Rs 1,005 apiece for an aggregate consideration not exceeding Rs 600 crore, it stated. Shares of the company were trading 0.38 per cent up at Rs 946.15 apiece on the BSE.

Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition. The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing. Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition, coronary artery disease, it added. The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the company said. Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual sales of USD 47 million in the US, Zydus said citing IQVIA December 2023 data. PTI RKL.

Zydus Group to invest Rs 5,000 cr across various sectors in Gujarat: Patel

Zydus Group on Friday announced plans to invest Rs 5,000 crore in Gujarat in various sectors, including new generation biotechnology products and hospitals, its Chairman Pankaj Patel said. Speaking at the 10th Vibrant Gujarat Global Summit here, Patel said his group has signed Memoranda of Understanding (MoUs) with the state for the investments. "We have signed MoUs of over Rs 5,000 crore. We'll be investing into next generation biotechnology products, new medical device initiatives and hospitals for the healthcare sector," he said. Patel said he has been attending the biennial summit since its inception and thanked Prime Minister Narendra Modi and Union Home Minister Amit Shah for helping businesses when it needs it the most. He said business needs leadership with a vision and the one that pushes it to think bigger, which is offered in Gujarat. Earlier, Nayara Energy's head of refinery Prasad Panicker said the company will be expanding its refinery at Vadinar and also upping its

Zydus Lifesciences gets USFDA nod to sell generic anti-epileptic medication

Zydus Lifesciences on Saturday said it has received approval from the US health regulator to market a generic anti-epileptic medication. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets in multiple strengths, the drug firm said in a statement. Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. The company said it will manufacture the product at the group's formulation manufacturing facility in Moraiya, Ahmedabad. As per IQVIA data, Lacosamide Tablets had annual sales of USD 249 million in the US.

Zydus, Daewoong collaborate to co-develop, market Leuprolide Acetate

Daewoong will leverage its proprietary technology to produce Leuprolide Acetate for Depot Suspension in its manufacturing facilities located in Osong, South Korea

Zydus gets USFDA nod for Zituvimet for type-2 diabetes mellitus treatment

The company said that Zituvimet has undergone quality testing for Nitrosamines and potential genotoxic impurities according to current FDA standards

Lupin's subsidiary, Generic Health gets Tiotropium 18 micrograms approval

The company has received the approval from Therapeutic Goods Administration (TGA)

Pharma companies seek price ceiling exemption for low-cost medicines

The industry and the government are on the same page on trade margin rationalisation, however, the industry wants it to be implemented in a phased manner

Zydus Lifesciences launches generic anti-epilepsy drug in US market

Zydus Lifesciences on Friday said it has launched generic epilepsy treatment medication in the US market. Zydus Pharmaceuticals (USA) Inc, a unit of the company, has launched Topiramate extended-release capsules in the American market. The company had earlier received final approval from the US Food and Drug Administration (USFDA) to market the product in strengths of USP 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a statement. Zydus is the first company to receive final approval and launch the medication in the above mentioned strengths, it added. Topiramate extended-release capsules are indicated for epilepsy: initial monotherapy in patients who are six years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated for prophylaxis of migraine in patients 12 years of age and older. As per IQVIA data, Topiramate extended-release capsule had annual sales of USD 488 million in the US.

Zydus gets DCGI nod for drug to treat anaemia linked with kidney disease

Zydus Lifesciences on Monday said it has received an approval from the DCGI for Oxemia (Desidustat), a first-of-its-kind oral treatment for anaemia associated with chronic kidney disease

Zydus gets regulator nod to market generic diabetes drug in American

Zydus Group on Wednesday said it has received final approval from the US health regulator to market diabetes medication Dapagliflozin tablets in the American market. The drug maker has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 5 mg and 10 mg. Dapagliflozin is used with a proper diet and exercise programme to control high blood sugar in people with type 2 diabetes. The drug also lowers the risk of heart failure in adults with type 2 diabetes with heart disease. It is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalisation for heart failure in adults with chronic kidney disease. Dapagliflozin works by increasing the removal of sugar by kidneys. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Group stated. The group now has 328 approvals and has so far fi

Zydus Pharma gets final USFDA approval to market Roflumilast tablets

Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug exclusivity

Zydus gets nod for phase 2 clinical study in Australian CAPS patients

Zydus Cadila on Monday said it has received approval to commence Phase II clinical study of its upcoming product with patients suffering with Cryopyrin-Associated Periodic Syndromein Australia.

Dr Reddy's Laboratories, Zydus Pharma recall products in US market

Dr Reddy's Laboratories, Inc, the US arm of Dr Reddy's Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg

Zydus Cadila gets USFDA nod for cancer, high blood pressure treatment drug

Drug firm Zydus Cadila on Thursday said it has received final approval from the US health regulator to market Ibrutinib Capsules, used to treat certain cancers

Zydus seeks DCGI nod for add'l indication of Hep C drug in Covid-19 therapy

In a likely breakthrough, interim results indicate that PegIFN when administered early on, could help patients recover faster and avoid complications seen in advanced Covid stages