DRUG MANUFACTURING COMPANIES
Drugs body flags side effects of heart, Glaucoma medications
The Indian Pharmacopoeia Commission has issued a drug safety alert regarding amlodipine and acetazolamide, highlighting potential adverse reactions. Healthcare professionals are advised to monitor for adverse drug reactions, while patients should be vigilant for any symptoms. Companies may be required to include warnings in drug packaging.
Dr Reddy's, Sun Pharma recall drugs in US market: USFDA
Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest USFDA Enforcement Report. Dr Reddy's is recalling insomnia and gout drugs, with 13,752 bottles of Eszopiclone tablets affected by failed impurities at their Bachupally plant. Sun Pharma is recalling 2,088 vials of Decitabine for Injection due to CGMP deviations at their Gujarat plant, prompting Class II recalls by both companies.
Zydus Lifesciences gets tentative approval from USFDA for BP lowering drug
Zydus Lifesciences announced on Thursday that it has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic Azilsartan Medoxomil tablets, which are used to treat high blood pressure. The USFDA's tentative approval covers Azilsartan Medoxomil tablets in strengths of 40 mg and 80 mg.
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said.
India to make drugs for diabetes, obesity under PLI by 2026, says report
India plans to incentivize local manufacturing of GLP-1 drugs, crucial for treating diabetes and obesity, starting in 2026, as per a government official speaking to Reuters. These drugs, originally approved for diabetes treatment, are also used for obesity due to their ability to slow digestion and reduce appetite. Novo Nordisk's patent on semaglutide, a key ingredient in popular drugs like Wegovy and Ozempic, is set to expire in India by 2026. Indian companies are already preparing to manufacture these drugs under the government's production-linked incentive (PLI) scheme.
Risk-based audits of drug units to begin from July 1
The revised Schedule M, which is considered more stringent than the World Health Organization's (WHO) good manufacturing practices (GMP) in certain areas, was notified on December 28, 2023. Companies with turnover of over ₹250 crore will have to comply with the upgraded version of Schedule M, starting July 1, and the remaining others, which are largely micro, small, and medium enterprises (MSMEs), have been given a year's time to comply. Inspections on those firms will begin from January 1, 2025.
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Indian regulator says 36% of inspected drug-making units had to be shut
India's drug regulator has ordered the closure of over 36% of its 400 drug manufacturing units since last year due to concerns over sub-standard cough syrups. The country, known as the world's pharmacy due to its large drug production, is working to restore confidence after the deaths of over 300 children worldwide linked to these syrups.
High costs of orphan drugs: Patients pay the price for policy hurdles in India
India manufactures APIs for over 400 FDA-approved orphan drugs, but patients face high costs due to Indian pharmaceutical companies' reluctance to develop these drugs domestically.
Lupin, Eugia recall products from US market: USFDA
Drugmakers Lupin and Aurobindo Pharma are recalling products from the American market due to manufacturing issues, as reported by the US Food and Drug Administration (USFDA). Lupin Pharmaceuticals Inc, a US-based unit of Lupin, is specifically recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) because of "failed content uniformity specifications."
View: India's pharma giants set sights on superior quality standards
India, known as the 'pharmacy of the world,' ranks third in global drug production and supplies vaccines to over 200 countries. With a target to reach $120-130 billion by 2030, maintaining high quality is crucial. Focus areas include robust investigations, skilled workforce development, and embedding quality in product development. India faces increased scrutiny from global regulators, necessitating adherence to stringent quality standards. Recent moves by CDSCO aim to streamline drug export licensing. Upholding quality is key for India's pharmaceutical industry to remain a reliable global supplier.
Manufacturing mutual funds offer up to 68% in one year. Should you consider?
Manufacturing mutual funds, including ICICI Prudential Manufacturing Fund and Mirae Asset Nifty India Manufacturing ETF, have delivered impressive returns up to 68% in the last year. Modi's 'Make in India' initiative has boosted the manufacturing sector, attracting investors to thematic and sectoral funds.
USFDA issues Form 483 with five observations to Torrent Pharma unit
Torrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspecting its manufacturing plant in Indrad, Gujarat, from June 3 to June 12. The inspection included a pre-approval inspection (PAI) and a Good Manufacturing Practice (GMP) inspection. The company stated that there were no observations related to data integrity. Torrent Pharma plans to respond to the USFDA within the prescribed time frame and work closely with the agency to address the observations promptly.
Ashish Kacholia offloads nearly 4 lakh shares of this smallcap manufacturing company
Ace investor Ashish Kacholia made a move on Tuesday by selling a portion of his stake in Ador Welding, a small-cap manufacturer renowned for its high-quality welding machines.
Indoco Remedies gets USFDA nod to market generic diabetes drug
Indoco Remedies on Thursday said it has received approval from the US health regulator to market a generic diabetes medication. The company has received tentative approval from the US Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Canagliflozin and Metformin Hydrochloride tablets in various strengths, Indoco Remedies said in a regulatory filing.
Govt issues guidance paper to strengthen vaccine companies' reporting of adverse events
The new report released last week aims to provide guidance to the manufacturers and importers of vaccines in the country so as to strengthen their AE/AEFI (adverse events following immunisation) monitoring and reporting and pharmacovigilance department to ensure patient safety.
Mutual fund houses roll out manufacturing sector-focused schemes; should you bet on this hype?
The buzz around manufacturing sector is driving AMCs to roll out new funds.
Panel to examine if nutraceuticals can be produced within drug unit
In a significant development, a five-member expert committee has been appointed to assess the feasibility of allowing the manufacturing of nutraceuticals within drug manufacturing facilities in India. This decision comes after the country's drug regulator had previously warned of taking action against those violating regulations by producing supplements and drugs in the same facility.
Dr Reddy's, Cipla, Sun Pharma & others to see FY25 revenue boost in key US market, says India Ratings and Research
Indian drugmakers, such as Dr Reddy's, Cipla, and Sun Pharma, are projected to maintain revenue growth in fiscal 2025, driven by drug shortages in the U.S. market. With 233 drugs in short supply, Indian companies are poised to benefit from the challenges faced by U.S.-based generic pharma manufacturers, leading to improved financial performance and increased market share in therapeutic categories.
Industrial policy is back. Is this what India needs for an ‘atmanirbhar’ economy?
Mere rise in GDP growth numbers are not enough. What India needs to become a global manufacturing powerhouse is a well-outlined policy that gets the wheel spinning on job creation, skills and holistic growth — especially as the world tilts towards protectionism.
Quest Labs stock debuts with 60% premium on NSE SME platform
Quest Laboratories made its debut on the NSE SME platform on Thursday, starting with a 60% premium. The stock opened at Rs 155, surpassing its issue price of Rs 97. Before its listing, the company's shares were trading at a premium of Rs 80 in the unlisted market.
US FDA inspects Vishakhapatnam facility of Solara Active Pharma
The US Food and Drug Administration (FDA) completes inspection of Solara Active Pharma Sciences' API manufacturing facility in Visakhapatnam, Andhra Pradesh, with no observations. Solara confirms compliance with FDA standards. The facility, dedicated to Ibuprofen API production, marks Solara's second successful FDA inspection. The company aims for global market expansion with FDA-approved facilities.
Dr Reddy's, Sun Pharma, Aurobindo recall products in US
The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems.
Serum Partners US company to advance needle-free injection technology
SII said, in a statement on Friday that the partnership with IntegriMedical aligns with its vision of 'Health for All' and IntegriMedical's mission to 'transform healthcare globally' by providing patient comfort, ensuring increased patient compliance, reducing needle-stick injuries, and enhancing the efficacy of liquid medication via needle-free dispersion.
Set up system for reporting adverse events: Regulator to medical device companies
The government mandates companies to carry out post-market surveillance (PMS) of medical devices with an aim to ensure the safety and performance of the devices.
Equipping leaders for the AI era: A CEO's toolkit
The critical juncture when AI is taking over the world slowly, a proactive approach and good understanding of Generative AI is required from leadership -- CEOs & CIOs.
USFDA issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unit
A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing.
Drug firms told to set up system for 'prompt' recalls
India enforced 'Schedule M' for drug manufacturers, emphasizing quality, recall systems. Companies must comply with strict rules on hygiene, audits, and reporting defects to DCGI for improved drug quality and safety measures. For seamless implementation of the new rules, the health ministry has been conducting workshops and giving presentations to pharma companies.
Pharmaceutical bodies welcome uniform marketing code
"We welcome the UCPMP. It is a balanced order that ensures that there is a healthy and ethical engagement between the pharmaceutical industry and medical professionals," Indian Drug Manufacturers' Association (IDMA) national president Viranchi Shah said. "It also brings clarity in the domain and has been updated as per current industry practices. The IDMA has always been in favour of ethical marketing practices for its members."
Sun Pharma recalls 55,000 bottles of generic drug from US market due to manufacturing norms violation
Sun Pharma is recalling 55,000 bottles of Febuxostat Tablets, in 40 mg and 80 mg strengths, from the American market due to manufacturing practice deviations caused by microbial contamination at their Dadra-based plant.
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