Zydus Cadila Strengthens Pipeline With 35 FDA Approvals

As Company Sees Double-Digit Domestic Growth

 
• By Akriti Seth
  
Generate a summary of this article
Listen to this article
Beta

India’s Zydus Cadila is working on strengthening its pipeline with 35 product approvals from the FDA over the course of its most recent financial year. The company also filed for 22 new ANDAs during FY2021. And ahead of recently launching the world’s first biosimilar to Roche’s Kadcyla (trastuzumab emtansine) in India, the company reported significant growth in its domestic business. 

FDA approvals
Zydus Cadila receives 35 FDA approvals and files for 22 new ANDAs • Source: Alamy

Zydus Cadila says it is “strengthening its regulatory pipeline” after receiving 35 abbreviated new drug application approvals from the US Food and Drug Administration during its financial year ended 31 March 2021. The company filed 22 additional ANDAs during the year as the company’s growing US formulations business registered revenues of INR15.09bn ($206.7m) in the fourth quarter alone.

Zydus Cadila noted that it has received 317 product approvals to date, while its cumulative filings have summed up to...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

SpotifyApple PodcastsWebsite

More from Products

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C7

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C6

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

US Biosimilars

An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

Amneal Kicks Off China Business With First Approval

Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.

More from Generics Bulletin

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C9

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C8

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C7

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.