1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

Geopolitics, US BIOSECURE: Pharma Looks To Redistribute CDMO Footprint

 
• By Anju Ghangurde

A senior McKinsey executive discusses trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.

Anirudh Roy Popli, Partner at McKinsey and Co., discusses Shifts In Pharma's CDMO Footprint.

Biopharma firms are rethinking their contract development and manufacturing organization (CDMO) network against the backdrop of geopolitical tensions and the advancement of the US BIOSECURE Act, but the size of the shift away from China in the short and long term remains in question.

Key Takeaways

  • The BIOSECURE Act is causing firms to considering moving contract manufacturing to other countries, including India.

  • But many firms said moving sites out of China in the next two years is unlikely

Two McKinsey surveys may perhaps indicate where things are headed

More from Manufacturing

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

More from Compliance

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.