Drug Makers

Lupin launches generic injection in US with 180-day exclusivity

Drug maker Lupin on Friday said it has launched a generic medication to treat schizophrenia in the US with 180 days of exclusivity. The company has launched Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US, the Mumbai-based drug maker said in a statement. This follows the recent approval received from the US Food and Drug Administration (USFDA). This is the company's first product using proprietary technology from PrecisionSphere, the Long-acting Injectable (LAI) platform developed by its subsidiary Nanomi BV. Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta LAI. It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults. As per IQVIA MA

Dr Reddy's launches novel drug for chronic constipation management

Dr Reddy's Laboratories on Tuesday said it has launched a first-in-class generic medication for chronic constipation in the country. The drug firm has launched Linaclotide, a first-in-class guanylate cyclase-C (GC-C), under the brand name Colozo. Linaclotide is a USFDA-approved medication indicated for adults suffering from chronic idiopathic constipation (CIC), irritable bowel syndrome with constipation (IBS-C) in adults, and functional constipation (FC) in paediatric patients aged 6 to 17 years. "The launch of Colozo marks a significant step in our gastrointestinal segment in India and adds to our list of novel and first-in-class drugs after the launch of BixiBat in India last year," Dr Reddy's CEO Branded Markets (India and Emerging Markets) MV Ramana said in a statement. With Colozo, the company continues to strengthen its commitment to deliver advanced therapies that meaningfully improve everyday patient care, in keeping with the goal to serve 1.5 bn patients by 2030, he ...

Novo Nordisk launches blockbuster weight-loss drug Wegovy in India

The 1.75 mg and 2.4 mg doses will be priced at ₹24,280, and 2.4 mg will be priced at ₹26,050 for a month

Wockhardt Q4 results: Drug maker's net loss shrinks to Rs 45 crore

Drug firm Wockhardt on Thursday reported a consolidated net loss of Rs 45 crore in the fourth quarter ended March 31, 2025. The drug maker had reported a net loss of Rs 177 crore in the January-March quarter of FY24. Revenue from operations rose to Rs 743 crore in the fourth quarter as compared to Rs 700 crore in the year-ago period, Wockhardt said in a regulatory filing. For FY25, the company said its net loss stood at Rs 57 crore as compared to Rs 472 crore in the year-ago period. Revenue increased to Rs 3,012 crore as compared to Rs 2,798 crore in 2023-24 fiscal. Shares of the company closed at Rs 1,347.75 apiece, 0.63 per cent higher from previous close, on the BSE.

Merck to invest $1 bn in new Delaware plant to boost US manufacturing

The company expects labs at the new facility to be fully operational by 2028 and produce experimental drugs by 2030

AstraZeneca gets nod to import, sell hyperkalaemia treatment drug in India

Sodium zirconium cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients

Contract drug makers urge govt to ease rules, reduce reliance on China

Contract drug manufacturers have gained from global companies' efforts to diversify their supply chain

Ex Pfizer CEO, CFO not to involve in Starboard's campaign on drugmaker

Pfizer's shares have fallen more than 9% in the past year and trade at around half of their pandemic-era highs as sales of its COVID products shrink

Lupin inks pact with Scope Opthalmics to market eyecare products in Mexico

Drug maker Lupin on Monday said it has inked a distribution pact with Ireland-based Scope Ophthalmics to market a product range, indicated for the treatment of various eye conditions, in Mexico. The company has signed a distribution agreement with Scope for the registration and marketing of Moist Heat Mask, a Tea Tree Oil Eyelid Cleansing Gel and Tea Tree Oil Eyelid Wipes of the Optase range in Mexico. The products are used for eye conditions like dry eyes, blepharitis and meibomian gland dysfunction (MGD). "This expansion of our ophthalmology range reinforces our commitment to enhancing vision care for our patients, improving their quality of life," said Fabrice Egros, President Corporate Development and Growth Markets, Lupin. Through the signature of this collaboration with Lupin, Scope is expanding its footprint in Latin America, Scope CEO Tom Freyne stated. "Mexico is clearly a country of strategic importance for SCOPE where our innovative eyecare products, together with the

Cipla to commence supplies to US from China plant later this year

Drug major Cipla expects to commence supplies to the US market from its China facility in the second half of the current fiscal after getting approval from the American health regulator, according to its MD and global CEO Umag Vohra. Addressing shareholders in the company's Annual Report for 2023-24, he noted that the company is working with the USFDA to resolve issues with its various domestic plants. "Although we saw challenging phases with USFDA audits, I am glad to report that our China facility cleared the USFDA audit and is expected to supply to the US by the second half of FY 2024- 25," Vohra said. Sharing updates about other plants, he noted that the facilities of Patalganga and Kurkumbh in India were also cleared with a VAI (voluntary action indicated). "Our Goa site was issued observations and our Indore plant is currently being remediated. Finding resolution for these regulatory issues continues to be our top priority," Vohra said. The company has worked extensively to

Lupin, Eugia recall products from US over manufacturing issues: USFDA

Drugmaker Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections. Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications". The affected lot has been produced at the company's Mandideep-based manufacturing plant in Madhya Pradesh. The company commenced the Class II nationwide (US) recall on May 30 this year. The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP. The company is recalling the affected lot due to "failed impurities/degradation specifications", USFDA said. Eugia com

Indian pharmaceutical companies likely to cash in on US drug shortages

US drug shortages hit a decade-high of 323 across 22 therapies in the March quarter of 2024

Cipla receives approval from drug regulator CDSCO for UTI drug

Plazomicin is a new intravenous (IV) aminoglycoside that has demonstrated efficacy and safety in clinical trials compared to meropenem (antibacterial agent)

Bristol Myers Squibb opens innovation hub worth $100 million in Hyderabad

"The state-of-the-art site will expand the company's global drug development and IT & digital capabilities and is expected to be home to over 1,500 employees," the company said in its release

Cipla forges strategic partnership for global cell therapy advancements

The collaborative effort is aimed at developing and commercialising novel Cell therapy products for critical unmet medical needs in the US, Japan, and the EU

US pipeline to keep pharma major Lupin's revenues on healthy trajectory

The stock of pharma major Lupin is up 14 per cent over the last eight trading sessions and is trading at Rs 1,406 a share. The gains are on expectations that margins will improve

Long use of e-cigarettes may lead to drug addiction, say health experts

Expressing concern over rising use of e-cigarettes among youths, health experts on Wednesday warned that practising such vaping methods may lead to addiction to drugs like cocaine and nicotine. 'Mothers Against Vaping' (MAV), a platform of concerned mothers combatting vaping among youths, cited several studies and said these devices harbour around 900-2,000 chemicals and can penetrate deep into the lungs, causing extensive and detrimental respiratory damage. "There exists a looming threat of an entire generation becoming addicted to these new-age tobacco devices, posing a significant risk to their health and well-being," Gauhati Medical College and Hospital Superintendent Dr Abhijit Sarma told PTI. It is imperative to take urgent comprehensive action to prevent the emergence of a new generation of e-cigarette smokers, he added. "Alongside this concerning trend, another issue is that these devices become gateway devices to more serious addictions like using cocaine and nicotine," Dr

Zydus unit recalls 7,248 bottles of Oxybutynin Chloride tablets in US

A unit of Zydus Lifesciences is recalling over 7,000 bottles of Oxybutynin Chloride tablets in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator said the drugmaker is recalling 7,248 bottles of Oxybutynin Chloride extended-release tablets, used to treat overactive bladder and urinary conditions, in the US. New Jersey-based Zydus Pharmaceuticals (USA) Inc. is recalling the affected lot due to "Failed Dissolution Specifications", the USFDA stated. The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated. The drug firm initiated the Class II recall on September 21 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse hea

WHO's good manufacturing norms to be made compulsory for all drug firms

Only 2,000 of the 10,500 manufacturing units in the country have the World Health Organization's GMP certification

Indian pharma industry to log in 8-10% revenue growth this fiscal: CRISIL

The Indian pharmaceuticals industry is expected to log in a revenue growth of 8-10 per cent in current fiscal aided by a steady domestic growth and increased exports to regulated markets, even as semi-regulated markets face headwinds, according to a report. A study of 186 drug makers, which accounted for about half of the Rs 3.7 lakh crore annual revenue of the sector last fiscal, indicates as much, Crisil said on Monday. "Similar to last fiscal, domestic growth in fiscal 2024, will be led by 5-6 per cent increase in realisations, supported partly by high price hikes allowed by the National Pharmaceutical Pricing Authority (NPPA) for drugs under price regulation," Crisil Research Director Aniket Dani said. In addition, sale of existing drugs and new launches will drive 3-4 per cent volume growth, he added. Operating profitability is also seen improving 50-100 basis points (bps) to 21 per cent this fiscal, supported by moderation in input and logistics costs, and abating pricing ...