China’s Global Pharma Supply Chain Operations Resuming In Wake Of Outbreak, USP Says

USP reference standard sales showed slow resumption of API manufacturing in China and less-than-expected API use in India.

China at night by VIIRS: This view of East Asia at night is a composite image assembled from data acquired by the Suomi National Polar-orbiting Partnership (Suomi NPP) satellite over nine days in April 2012 and thirteen days in October 2012
China getting back up and running after coronavirus outbreak • Source: NASA Earth Observatory, November 2012

China’s pharmaceutical manufacturing areas began recovering from coronavirus-related travel restrictions in mid-February, with production back up to half the normal rate, says US Pharmacopeia CEO Ron Piervincenzi.

The USP could detect that by reviewing Chinese sales of its physical reference standards.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Generics

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By 

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

US FDA Maintaining Approval Output Despite Losing Staff

 

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By 

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By 

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

More from Biosimilars & Generics

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.