Passez à l'illimité avec Magzter GOLD
Obtenez un accès illimité à plus de 9 000 magazines, journaux et articles Premium pour seulement
Cipla: USFDA approval clears path for Abraxane launch
Financial Express Chennai
|April 15, 2025
CIPLA ANNOUNCED ON April 11 that it has received final approval from the USFDA for its Abraxane (Paclitaxel protein-bound particles for injectable suspension [albumin bound], 100 mg/vial, single-dose vial) ANDA.
-
The approval pertains to Cipla's Goa site, which was cleared by the USFDA in October 2024. While the approval is not entirely unexpected, there were concerns about potential delays due to the possibility of a pre-approval inspection. However, we think the approval thus presents visibility on launch. Cipla expects to launch the product in the first half of FY26, earlier than its initial guidance of a second-half FY26 launch. However, as production ramp-up and supply initiation may take time, we anticipate the launch to occur towards the end of 1HFY26.
Cette histoire est tirée de l'édition April 15, 2025 de Financial Express Chennai.
Abonnez-vous à Magzter GOLD pour accéder à des milliers d'histoires premium sélectionnées et à plus de 9 000 magazines et journaux.
Déjà abonné ? Se connecter
PLUS D'HISTOIRES DE Financial Express Chennai
Financial Express Chennai
Strong debut for ICICI PruAMC
· Settles 19.5% above IPO price
1 min
December 20, 2025
Financial Express Chennai
Practo to seek banks for 2026 IPO
PRACTO TECHNOLOGIES, WHICH runs a digital health platform, is planning an initial public offering, according to people familiar with the matter, joining a wave of companies rushing to capitalise on India's buoyant market for first-time share sales.
1 min
December 20, 2025
Financial Express Chennai
Electronics is the dark horse in India-China trade
Trade deficit at new record low of $106 bn in 2025
1 min
December 20, 2025
Financial Express Chennai
Yen weakens across board after BOJ delivers rate hike
CENTRAL BANK SAYS IT WILL KEEP RAISING RATES IF FORECASTS MATERIALISE
1 min
December 20, 2025
Financial Express Chennai
Coca-Cola India profit up 46.3% to ₹615 crore
Revenue rises 7% in FY25
1 min
December 20, 2025
Financial Express Chennai
Funds for rural roads scheme see gross underutilisation
STATES’ SPENDING CAPACITY LIMITED
2 mins
December 20, 2025
Financial Express Chennai
China to allow export of rare earths for civilian use
CHINA ON FRIDAY said it will approve export of its rare-earth metals for civilian use, amid India's persistent calls for Beijing to lift curbs and resume the export of precious metals needed to manufacture a host of modern products.
1 min
December 20, 2025
Financial Express Chennai
How winter pushes every car to its limits
BE IT ICE CARS OR EVS, THE SEASON CAN BE TOUGH
2 mins
December 20, 2025
Financial Express Chennai
Goyal to visit Brussels to push EU FTA talks
COMMERCE AND INDUSTRY Minister Piyush Goyal will visit Brussels on January 8—9 to push forward negotiations on the free trade agreement (FTA) with the European Union (EU), which have gained momentum as both sides move closer to the India-EU Summit next month.
1 mins
December 20, 2025
Financial Express Chennai
'Expect a couple more REITs to come in by 2026'
While residential markets faced headwinds this year, the office sector recorded 60 million square feet of gross leasing between January and September 2025, the highest for the first nine months of any year.
2 mins
December 20, 2025
Listen
Translate
Change font size