Poging GOUD - Vrij
Cipla: USFDA approval clears path for Abraxane launch
Financial Express Chandigarh
|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.
Dit verhaal komt uit de April 15, 2025-editie van Financial Express Chandigarh.
Abonneer u op Magzter GOLD voor toegang tot duizenden zorgvuldig samengestelde premiumverhalen en meer dan 9000 tijdschriften en kranten.
Bent u al abonnee? Aanmelden
MEER VERHALEN VAN Financial Express Chandigarh
Financial Express Chandigarh
NCLT clears Flipkart's shift from Singapore to India
THE NATIONAL COMPANY Law Tribunal (NCLT) has approved Flipkart's longpending proposal to shift its domicile from Singapore to India, clearing a critical regulatory hurdle as the Walmart-owned e-commerce major readies itself for a domestic public listing.
1 mins
December 16, 2025
Financial Express Chandigarh
Growth over last decade has been broad-based: FM
ACTUAL HOUSEHOLD CONSUMPTION data point to a decisive shift in India's growth trajectory, with the bottom 40% (B40) of the population accumulating wealth and assets far faster than the top 20% (T20), driving a sharp compression in inequality, Finance Minister Nirmala Sitharaman said on Monday.
1 min
December 16, 2025
Financial Express Chandigarh
Govt holds road shows for share sale in GIC
THE GOVERNMENT HELD road shows in London to assess investor interest for a minority stake sale in General Insurance Corp (GIC), two government sources familiar with the matter told Reuters.
1 min
December 16, 2025
Financial Express Chandigarh
Navi Mumbai airport may add 3rd runway
Feasibility study launched by CIDCO to assess rising air traffic in MMR
1 min
December 16, 2025
Financial Express Chandigarh
ICICI Pru AMC IPO fully booked on Day 2
THE INITIAL PUBLIC offering of ICICI Prudential Asset Management Company, an arm of the ICICI Bank, was fully subscribed on the second day of share sale on Monday, led by institutional investors.
1 min
December 16, 2025
Financial Express Chandigarh
Rupee slides to another record low
THE RUPEE'S DOWNWARD slide continued on Monday, ending at a new low of 90.73 against the dollar—down 31 paise—on weak market sentiment.
1 min
December 16, 2025
Financial Express Chandigarh
Nov wholesale inflation stays in negative zone
WHOLESALE PRICE INFLATION remained in negative territory for the second consecutive month in November, primarily due to a decrease in the prices of food articles, mineral oils, crude petroleum & natural gas, basic metals and electricity, the government data released on Monday showed.
1 mins
December 16, 2025
Financial Express Chandigarh
Create more space to let solar power flow
Solar power is auctioned almost every fortnight and developers are actively securing capacity, so boosting transmission network is crucial to reap benefits
3 mins
December 16, 2025
Financial Express Chandigarh
AIRBEA CALLS FOR ADEQUATE SUPPLY RBI union flags small value notes crunch
HIGHLIGHTING CONCERNS OVER an acute shortage of small denomination currency notes in the country, the All India Reserve Bank Employees Association (AIRBEA) has urged the Reserve Bank of India (RBI) to ensure adequate supply of these notes.
1 mins
December 16, 2025
Financial Express Chandigarh
Rural jobs scheme reloaded
THE RENAMED AND updated MGNREGA seeks a complete overhaul of the 2-decade-old programme to curb rampant leakages. A look at the key changes
1 min
December 16, 2025
Listen
Translate
Change font size