1. Generics Bulletin
  2. >>Business
  3. >>Manufacturing

FDA Warning Letter Blasts Mylan’s Lax API Impurity Controls

Cites Equipment Cleaning And Monitoring Of Recovered Solvents For Impurities

 
• By Joanne S. Eglovitch

Concerned about another possible nitrosamine scare, the US FDA has sent a warning letter to Mylan focusing on the firm’s failure to control contamination risks of its APIs and inadequate testing of reused solvents.

Vintage inscription made by old typewriter, warning
FDA Tells Mylan To Learn From Earlier Mistakes • Source: Shutterstock

A warning letter the US Food and Drug Administration sent on 20 August to Mylan targets the firm’s lax cleaning procedures for equipment holding and manufacturing active pharmaceutical ingredients and a failure to test reused solvents used to make APIs at the Mylan Unit 7 facility in Pashamylaram, India.

The warning letter underscores the FDA’s concern with the possibility of another nitrosamine scare that emerged from the 2018...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
• By Dean Rudge

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
• By Dean Rudge

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Glenmark Adamant FDA Monroe Site Reinspection Could Happen ‘Any Time’

 
• By Dean Rudge

A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

More from Business

Teva Continues Push Beyond Generics in Fosun Immunotherapy Tie-Up

 
• By Dean Rudge

Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w

Big Top-Level Shifts At Sun: Ganorkar Is MD, Ex-Takeda Exec To Helm US Business

 
• By Anju Ghangurde

Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

 
• By Dean Rudge

In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.