Aurobindo Pharma arm gets U.S. FDA nod for generic of BMS' cancer drug
Aurobindo Pharma subsidiary Eugia Pharma Specialities has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Dasatinib Tablets in different strengths.
Bioequivalent and therapeutically equivalent to the reference listed drug Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), the product is expected to be launched by June. The approved product has an estimated market size of $1.8 billion for the twelve months ending February 2025, Aurobindo said, citing IQVIA MAT numbers.
Dasatinib Tablets is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in chronic phase; adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy; and adults with Ph+ acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, the company said.
This is the 181st ANDA approval, including nine tentative approvals received, out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Standard
21 hours ago
- Business Standard
OneSource Specialty jumps as Bangalore facility passes USFDA check
OneSource Specialty Pharma rose 3.98% to Rs 2,006 after the company announced that its flagship drug-device combination facility in Bangalore has retained its compliance status with the U.S. Food and Drug Administration (USFDA). The facility received a "Voluntary Action Indicated" (VAI) classification from the USFDA, following an inspection conducted between March 20 and March 28, 2025. During the inspection, the agency issued a Form 483 with four observations. However, after reviewing the company's comprehensive response and commitments, the agency has officially closed the inspection. Neeraj Sharma, managing director & CEO, said "The successful closure of our latest USFDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in Drug Device Combinations (DDC), biologics drug substances, and complex injectables. This milestone validates our deep-rooted commitment to quality and is crucial as our partners prepare to launch key GLP-1 products in late FY26. We are excited to advance into our next significant commercial phase." OneSource Specialty Pharma is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals. On a consolidated basis, OneSource Specialty Pharma reported net profit of Rs 98.50 crore in Q4 March 2025 as against net loss of Rs 40.17 crore in Q4 March 2024. Net sales surged 482.38% YoY to Rs 425.95 crore in Q4 March 2025.
Time of India
5 days ago
- Time of India
API prices fall sharply, easing pressure on India's pharmaceutical industry
India's pharmaceutical industry is experiencing relief as active pharmaceutical ingredient (API) prices plummet due to overcapacity and aggressive pricing strategies from Chinese suppliers. Increased domestic API production, driven by government incentives and reduced raw material costs, further contribute to the decline. This trend is expected to continue, boosting profit margins for Indian pharma companies. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads New Delhi: Prices of active pharmaceutical ingredients (API) used for manufacturing drugs are seeing a significant drop, bringing relief to India's pharmaceutical pharma industry depends largely on China for sourcing APIs, intermediates and bulk drugs. API prices had shot up during the Covid period and stayed elevated until last year. The situation has now started to change, reducing raw material cost and boosting profit margins for pharma instance, the price of paracetamol API has dropped from ₹900 per kg during the pandemic and ₹600 immediately after to ₹250 now, market sources told ET. The API for antibiotic meropenem has become cheaper at ₹45,000 per kg compared with ₹75,000."Prices of APIs have gone down significantly. It's largely due to over-capacity. We are seeing a huge impact on the prices of antibiotics, steroids, hormones, statins, among others," said Mehul Shah, who tracks the Chinese pharmaceutical expects this trend to continue through this industry expert said the prices have come down because of the aggressive strategy of Chinese suppliers to maintain market dominance. "This aggressive pricing has made Chinese APIs more attractive to Indian pharmaceutical companies, leading to increased imports when prices are low," he said on the condition of anonymity. Dinesh Dua , former chairman of the Pharmaceutical Export Promotion Council, said there were several factors that led to the price decline."While China scaled up significantly after Covid-19, the demand for APIs has gone down too as India has taken steps to become self-reliant," he said. "India's government has implemented the production-linked incentive scheme to boost domestic API production. As a result, companies like Aurobindo Pharma and Torrent Pharmaceuticals have initiated local production of APIs such as penicillin-G. This increased domestic output has contributed to a surplus in supply, exerting downward pressure on prices."Dua said a decline in the prices of raw materials, such as acetic acid and para-aminophenol, essential for API production, has also contributed to lower costs. "Additionally, easing geopolitical tensions and improved logistics have reduced freight charges, further decreasing the overall cost of API," he to industry experts, a gradual return of demand to pre-pandemic levels has also contributed to this situation.
Hindustan Times
6 days ago
- Hindustan Times
US faces vape shortage as China tariffs, seizures hit Geek Bar
LONDON, - Popular vape brands like Geek Bar may get more expensive in the U.S. - if you can find them at all. Shipments of vapes from China to the U.S. ground to a near halt in May from a year ago, official data shows, hit by U.S. President Donald Trump's tariffs and a crackdown on unauthorised e-cigarettes in the world's biggest market for smoking alternatives. That includes Geek Bar, a brand of flavoured vapes that is not authorised to sell in the U.S. but which had been widely available due to porous import controls. One retailer, who asked not to be named because their business sells unauthorised vapes, told Reuters that one of the store's vape suppliers normally receives 100 boxes of Geek Bar vapes per week, but is now getting just ten. Another supplier imposed unprecedented purchase limits. "There were a lot of supply chain issues' during COVID-19, the person said. "But I've never seen this." The U.S. supplier limited purchases to five boxes at a time due to "tariff-related price increases and limited market availability", an undated notice to customers seen by Reuters showed. Trump's decision to impose steep tariffs on China, now at 30% after peaking at 145% in April, as well as blockbuster seizures of unauthorised vapes, have constrained the supply of Chinese-owned vape brands and Geek Bar in particular, according to five industry sources and notices from U.S. Geek Bar wholesalers reviewed by Reuters. Between May 1 and May 28 the U.S. Food and Drug Administration recorded just 71 shipments of products labelled as e-cigarettes or vapes from China, compared with nearly 1,200 over the same period last year. Such imports had fallen between 40% and 60% in February, March and April, after Trump came into office, but collapsed in May, the data show. "Due to increased tariffs, rising production costs, and reduced supply chain capacity, the manufacturer has informed us that they will be reducing supply volume in the near-term," one U.S. regional Geek Bar wholesaler wrote to customers on April 22 in an email shared with Reuters. 'WE'RE TALKING ABOUT NICOTINE HERE' In the meantime, vape distributors expect prices to go in one direction. "With tariffs, it'll definitely go up," said one U.S. vape distributor who asked not to be named. But that might not impact sales much. Unauthorised vape manufacturers enjoy hefty margins, and so can eat some of the cost of tariffs, Luis Pinto, a spokesperson for British American Tobacco's U.S. subsidiary, said. Meanwhile, consumers hooked on vapes tend to keep buying, even as the price goes up. "If the price goes up, the price goes up. We're talking about nicotine here," the vape distributor said, adding unlike other products, addicted users need their fix. Vapes like Geek Bar - priced around $20 currently - would still be good value even with a $5 increase, the person said. Geek Bar manufacturer, Guangdong Qisitech, did not respond to a request for comment sent to its general email address. Pinto agreed the tariffs will increase prices but probably not to the point "where it is a barrier to usage". Many of the vapes landing on U.S. shelves are manufactured in Shenzhen, which meets the majority of the world's demand for vapes. Some factories there make devices for large tobacco companies with the legal licence to sell their products in the United States, such as Japan Tobacco International. Others fuel a booming market for unregulated devices that U.S. authorities say are illegal to import or sell. To mitigate tariffs, illicit vape producers can mislabel or undervalue their shipments or spoof their origin entirely to make it look like they came from a lower-tariff country like Indonesia, Vietnam or Mexico, Pinto said. Vapes from China are often smuggled into the U.S. disguised as other items entirely, such as shoes or toys, to evade officials hunting for unauthorised vapes at the border, according to public statements from the FDA and Customs and Border Protection. Geek Bar was by far the most popular unauthorised vape brand in the U.S. last year, accounting for around a quarter of sales tracked by market research company Circana in 2024 despite lacking a licence to sell from the FDA, which has struggled to contain illegal imports from China. The brand, as well as thousands of other labels often made in China and lacking FDA permission, are stocked by wholesalers and retailers around the country, often sold alongside authorised labels from big tobacco companies like BAT and Altria . PANIC BUYING U.S. tariffs have driven panic buying of vapes by U.S. buyers, higher shipping costs and increased risks at the border, the distributor, a former distributor and a person who used to work for a major Chinese vape company said. Substantial vape seizures were also a big driver of Geek Bar supply issues, two of the sources said. The FDA announced a large seizure in Chicago in February, and new FDA commissioner Marty Makary has pledged to crack down on unauthorised vapes. Government notices on seized goods show further vape seizures in March and April. The growth of Geek Bar and other unregulated vape brands have eaten into the market share of cigarette companies like Altria and BAT, which estimates unauthorised e-cigarettes accounted for some 70% of all U.S. vape sales last year. Altria CEO Billy Gifford told investors in April that he hoped tariffs would lead to "much more enforcement" of vapes at the border. Trump's trade war with China has also seen China-U.S. air freight and shipping capacity collapse limiting shipping capacity for cargo including vapes. The FDA's data only captures shipments properly declared as vapes. As a result, it has recorded declining vape shipments since 2020 even as industry sales have grown. An FDA spokesperson said the agency expects the number of shipments it captures to increase as it ramps up efforts to ensure compliance and prevent illegal imports. Unauthorised vape makers have also been moving production to Indonesia - a shift that prolonged tariffs on China would likely accelerate, the former employee said. Vape makers are "highly adaptable", the person said. "Whatever happens in the U.S., the industry will survive."
