Drug Makers

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

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

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

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

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

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

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

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

"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

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

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

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

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

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

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 ...

Cash-strapped Pakistan's drugs regulatory watchdog has said that hospitals and common citizens can import vital medicines, including anti-cancer drugs and vaccines, from India for their use, a media report said on Friday. The Drug Regulatory Authority of Pakistan (DRAP) said on Thursday that there was no restriction on hospitals or the common man on importing vital medicines (anti-cancer drugs and vaccines) from India for their own use under the Import Policy Order 2022 after obtaining no objection certificate (NOC) from the authority, The News International newspaper reported. The statement of the DRAP officials came during a session of the Senate Standing Committee on Health when Senator Professor Mehr Taj Roghani raised the issue of the unavailability of several essential medicines in the country amidst a financial crisis. In view of (the) unavailability of some essential medicines in Pakistan, common people and hospitals can apply for a NOC to directly import medicines from Indi

Authorities have stepped up scrutiny of drugmakers after some cough syrups made in India were linked to deaths of dozens of children overseas

Objective of drug regulation is to ensure safety, efficacy, and quality of drugs

Its local production ramp-up remains unhurried as demand for boosters reduces

Discovered in 1970, the drug was tested on severe Covid-19 patients on DCGI's direction