Page 33 - Pharma Sector

DCGI asks states to keep vigil on sale of falsified versions of 2 drugs

The Drugs Controller General of India (DCGI) has directed the drugs controllers of all states and Union territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda's cancer drug Adcetris (injection), following alerts issued by the World Health Organisation (WHO). In an advisory on September 5, the DCGI said the WHO has issued a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India. "These products are most often available at the patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation," the DCGI said in a communication to the

Glenmark eyes double-digit revenue growth; to focus on debt reduction

Glenmark Pharmaceuticals aims to grow its revenues by 10-11 per cent with a focus on free cash generation to reduce debt in the current financial year, according to Chairman and Managing Director Glenn Saldanha. The Mumbai-based drug major is also looking at enhancing EBITDA margins while expanding presence in various therapeutic segments like oncology and dermatology. "For the new financial year, we aim to grow by 10-11 per cent in revenues, expand our EBITDA margin to 19-20 per cent, and continue to focus on enhancing free cash generation for further debt reduction," Saldanha said in the company's Annual Report for FY23. In FY23, the company's consolidated revenue from operations stood at Rs 12,990 crore, up from Rs 12,305 crore in FY22. Besides, the drug maker reported an EBITDA of Rs 2,278 crore during the 2022-23 fiscal with margins at 17.5 per cent. Glenmark reported net debt of Rs 2,905 crore for the fiscal ended March 31, 2023. Addressing the company's shareholders, he not

Strides Pharma gets USFDA approval for generic Sevelamer Carbonate

Strides Pharma Science Ltd on Saturday said its arm, Strides Pharma Global Pte Ltd Singapore, has received approval from the US health regulator for its generic Sevelamer Carbonate for oral suspension indicated for patients with chronic kidney disease on dialysis to prevent dangerous increases in phosphates. The approval by the US Food & Drug Administration (USFDA) is for Sevelamer Carbonate for oral suspension of strengths 0.8g and 2.4g, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug Renvela for Oral Suspension, 0.8g and 2.4g of Genzyme, the company said. "The approval completes the company's Sevelamer Carbonate portfolio...The product is a complex generic with limited players having both the tablets and oral suspension," it said adding, the approved medicine will be manufactured at the company's facility in Bengaluru. The Sevelamer Carbonate market for both tablets and oral Suspension ..

Siddhanta Medicity partners with UK firm to raise $108 mn for cell therapy

Bhopal-based healthcare institution Siddhanta Medicity looks to raise around USD 108 million (around Rs 826 crore) in partnership with a UK-based firm for advancing clinical research and development in the field of cell therapies, a release said on Saturday. The investment of USD 108 million will play a pivotal role in establishing stem cell research centres, treatment facilities, and advanced laboratories, Dr. Subodh Varsheny, the managing director of the Bhopal-based health institution said. The institution has tied up with UK-based SRAM &AM Group to raise funds to advance clinical research and development in the field of NK Cell and Mesenchymal Stem Cell Therapies, the statement said. The SRAM &AM Group has also tied up with biopharmaceutical company Cellaax, which is engaged in the research and development of advanced cellular therapy.

Natco Pharma, Celgene Corp, others sued in US for generic cancer drug

Natco Pharma on Friday said the company and other drug makers have been named defendants in an antitrust lawsuit regarding a generic cancer treatment drug in the US. The Hyderabad-based drug firm along with Celgene Corporation, Bristol Myers Squibb, Breckenridge Pharmaceutical Inc and others have been named defendants by Louisiana Health Service & Indemnity Company, D/B/A Blue Cross and Blue Shield of Losisiana and HMO Louisiana Inc, regarding anti-cancer treatment medication Pomalidomide. The company believes this matter is without merit, Natco Pharma said in a statement. Breckenridge is the abbreviated new drug application (ANDA) holder and distribution partner for the generic product in the US, it added. Natco Pharma shares were trading 3.13 per cent down at Rs 885.00 apiece on the BSE.

After drive against spurious drugs, DCGI collating data on pharma plants

The DCGI, in a letter dated September 4, has instructed state drug controllers to obtain the details from the firms under their jurisdiction

DCGI issues advisory as US-based Abbott recalls batches of Digene gel

The DCGI has cautioned against the consumption of Abbott's antacid Digene gel citing safety concerns, even as the US-based drugmaker recalled several batches of the medicine manufactured at its Goa facility. According to a letter by the Drugs Controller General of India (DCGI), it was reported on August 9 that a bottle of Digene Gel (mint flavour), batch no 51030307, used by customers was of regular taste (sweet) and light pink in colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per a complaint. "Accordingly, M/s Abbott India Limited, Verna Industrial Estate, Salcette, Goa- vide letter dated August 11, 2023, informed DCGI office for voluntary recall of impugned product Digene Mint flavour batch no 51030307 and Digene Gel orange having batch no 50035107, 50035207, 50035307, 50035407 and voluntary stopped production of all variants of Digene Gel manufactured at their Goa facility," the DCGI letter stated. Further, Abbott India

Biocon Biologics completes integration of Viatris biosimilars business

Biocon on Wednesday said its arm Biocon Biologics has completed the integration of the acquired biosimilars business from Viatris in North America with effect from September 1, 2023. Since the acquisition agreement closed in November 2022, Biocon Biologics has executed a robust integration plan to ensure a seamless transition of partners, people, systems, and processes, Biocon said in a regulatory filing. In February 2022, Biocon Biologics had inked a pact to acquire Viatris Inc's biosimilars business for a consideration of up to USD 3.33 billion (about Rs 24,990 crore). Later, in November same year the company completed the acquisition. "Our successful North America (US and Canada) transition marks the second wave of our integration of the Viatris biosimilars' business, quickly following Emerging Markets and ahead of schedule," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said the company would be leading the commercial operations in the US and Canada

Ind-Swift Labs to sell pharma ingredients ops to Synthimed Labs for $198 mn

Ind-Swift Labs will sell its active pharmaceuticals ingredients (API) and contract research and manufacturing services (CRAMS) business

Generic medicines: Indian pharma market is at crossroads of systemic shift

Companies must start preparing their business models to adjust to the reality of the shift to medical practitioners prescribing only generic molecule names

2,000 bottles of banned cough syrup seized, three arrested in Bengal

Around 2,000 bottles of banned cough syrup Phensedyl were seized and three people were arrested on Tuesday in West Bengal's Nadia district which borders Bangladesh, police said. Acting on a tip-off, police intercepted two vehicles in Natunpara in Bhimpur police station area and seized the cough syrup bottles, while arresting the occupants, a police officer said. The arrested persons are residents of Nadia's Karimpur, which is close to the India-Bangladesh border. Phensedyl contains codeine, which is a narcotic drug that causes addiction when used in large quantities over a period of time. The cough syrup is used as an intoxicant in Bangladesh as an alternative to alcohol.

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Centre invites bids for privatisation of Indian Medicines Pharmaceutical

Interested buyers in Indian Medicines Pharmaceutical should submit initial bids to the government by Oct 15, according to the government document

Govt likely to extend export benefits under RoDTEP scheme for pharma, steel

The government is expected to extend export benefits under the RoDTEP scheme to iron and steel, chemicals and pharmaceutical sectors beyond September 30, according to a senior official. In December 2022, the government extended the benefits under the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme to chemicals, pharmaceuticals and products of iron and steel till September 30 this year. "As exports are not doing good for the last few months, there is a demand to extend it for about six months till March 2024. It is under consideration. We may extend it," the official said. These three sectors were late entrants into the scheme that aims to refund duties, taxes and levies at the central, state and local level that gets added to the cost of products meant for exports. This scheme is a replacement for the Merchandise Exports from India Scheme (MEIS) which ended last year. At present, over 10,342 export items get the RoDTEP benefits. The incentive is paid in the for

Strides Pharma arm gets USFDA approval for generic Mycophenolate Mofetil

Strides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection. The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added. The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products, it added. The product will be manufactured at the company's facility in Bengaluru, Strides said. Mycophenolate Mofetil for oral suspension has a market size of USD 41 million, the company said citing IQVIA data.

Lupin gets USFDA nod to market generic lung disease treatment capsule

Pharma major Lupin Ltd on Tuesday said it received approval from the US health regulator to market its generic Pirfenidone capsules used for the treatment of lung disease known as idiopathic pulmonary fibrosis. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing. The drug is the generic equivalent of Esbriet Capsules, 267 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin's Pithampur facility in India, it added. Pirfenidone capsules had estimated annual sales of USD 95 million in the US, Lupin said citing IQVIA MAT June 2023 data.

India aspires to become global leader in innovative drugs: Report

This will lead to a sustained global competitive advantage and contribute to quality employment generation in the country

Billion-dollar pharma cos set to face their first US price negotiations

For taxpayers, the savings could be significant: Negotiations could save the US $36.5 bn from 2026 to 2028, according to Wells Fargo Securities. Drugmakers are suing the government to stop the squeeze

Economy on growth path; auto, pharma, tourism sectors to add new jobs: PM

Prime Minister Narendra Modi on Monday said the Indian economy was on the path of rapid growth which had led to creation of big opportunities for employment of the youth. Addressing a Rozgar Mela where he distributed over 51,000 appointment letters to the youth, he said automobile, pharma, tourism and food processing sectors were expected to grow at a rapid pace and open up employment opportunities for the youth. Modi addressed the Rozgar Mela virtually as the new appointees in central paramilitary forces, Narcotics Control Bureau and the Delhi Police joined in from 45 locations across the country. The prime minister said India had emerged as the fastest growing economy and would soon be among the top three economies in the world during this decade and bring benefits to the common man. "For any economy to grow, it is imperative that every sector develops. From the food sector to pharmaceuticals, from space to start-ups, when every sector grows the economy will move ahead," he said

Drug retailer Rite Aid Corp preparing to file for bankruptcy: Report

Regionally focused Rite Aid operates more than 2,330 stores in 17 U.S. states, although it is much smaller than rivals like Walgreens Boots Alliance and CVS Health