• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Hygienic Packaging Technology

    Trends in Solid Oral Dosage Delivery

    5 Reasons Paper Has No Place in Contract Manufacturing

    Injectable Drug Delivery Trends

    Pharmaceutical Manufacturing Equipment Trends
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Amgen to Acquire Five Prime Therapeutics for $1.9B

    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions

    CureVac, Novartis Ink COVID Vax Mfg. Pact

    Innoforce and dMed Enter Development Collaboration

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Reed-Lane Facility Virtual Tour

    CureVac, Novartis Ink COVID Vax Mfg. Pact

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    WuXi AppTec Completes OXGENE Acquisition

    Trends in Solid Oral Dosage Delivery
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Reed-Lane Facility Virtual Tour

    Hygienic Packaging Technology

    Reshaping the Pharmaceutical Supply Chain

    Serialization: Level 5 Solution

    Covectra Introduces Next-Gen Serialization Solution
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions

    Innoforce and dMed Enter Development Collaboration

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    Four Female Leaders Appointed to Cell & Gene CDMO

    Strata Oncology Unveils Strata PATH Trial
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Guide to Maintaining Validation of Older Facilities: Why, When and How

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Emergent BioSolutions

    Alcami

    Baxter BioPharma Solutions

    Almac Group

    PCI Pharma Services
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Syngene

    Adare Pharma Solutions

    Almac Group

    Emergent BioSolutions

    PCI Pharma Services
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Expert's Opinion

    Are the Challenges of Chinese API Manufacturing Sparking a Shift Back to the US?

    Five challenges that face U.S. and Chinese API manufacturing relations.

    Are the Challenges of Chinese API Manufacturing Sparking a Shift Back to the US?
    Ed Price, President, Seqens North America06.19.20
    According to McKinsey & Company, “Biopharma market growth in China has remained in the mid-single figures over recent years, with total value reaching some $130 billion in 2018, making China second only to the United States in world rankings.” Since then, China’s market share has continued to surge in the development of critical active pharmaceutical ingredients (APIs) and New Chemical Entities (NCEs). In fact, 80 percent of manufacturing ingredients are produced in China.

    The Chinese market growth is attributed to the fact that its contract development and manufacturing organizations (CDMOs) have offered cheaper alternatives to U.S. CDMOs. The lower costs Chinese manufacturers offer for critical drugs, such as popular antibiotics, have caused many U.S. plants to shutter their doors, since they simply could not compete on price.

    Given growing quality concerns, creeping prices that are shrinking the cost gap, and now most recently, the coronavirus which has brought production to a halt, a shift back to U.S. manufacturing, may be just on the horizon. 

    In addition to these reasons, this NBC News piece spotlighted the fact that there is growing concern in the U.S. that our reliance on APIs and drug products produced in China could be a national threat because of their potential to be cut off from U.S. patients or weaponized in the event of growing hostile relations with the U.S. Given this concern, increasing government intervention to reinvigorate our manufacturing capabilities will spur a rise in U.S. manufacturing as well. 

    Five Challenges of Doing Business In China

    While for several years now, there have been undeniable cost benefits of doing API manufacturing in China, and this will continue in many cases, the challenges are becoming too difficult to ignore and will contribute to a resurgence of manufacturing in the U.S. Below is a closer look at these challenges.
     
    1. Sheer logistics. Because of different time zones and cultural and language barriers, as well as the growing focus on collaboration between sponsors and CDMOs, working with Chinese CDMOs will increasingly becoming more difficult.
     
    2. Quality concerns. Recently the problems of tainted drugs from China have dominated the news. An article in The New York Times shared information from an FDA inspector who exposed fraud or deceptive practices in almost four-fifths of the drug plants he inspected in China and India over a five-year period. These practices included tampering with or falsifying reports, re-testing drugs to get the desired results and operating within unsterile environments. Also, according to an article in Statnews, in 2018, “the FDA recalled a number of blood pressure medications made in China that were contaminated with N-nitrosodimethylamine (NDMA), a cancer-causing toxin.”
     
    For many years the Chinese facilities were not inspected, but the advent of stricter inspection policies as a result of the Generic Drug User Fee Amendments (GDUFA) increased the FDA’s ability to fully inspect offshore facilities. Despite this closer scrutiny, the FDA has fallen short of keeping up with inspections in China, because of sheer logistics, as well as growing FDA regulatory complexity.  
     
    3. Pandemic outbreak. Plants located in hotbeds of Chinese manufacturing, such as Wuhan, have been closed due to coronavirus, virtually stopping the export of critical ingredients to the U.S. as well as other regions. It also has halted inspections by the FDA of drugs imported from China, which can jeopardize the delivery of drugs to patients who desperately need them. The pandemic reinforces the vulnerability of the U.S. when relying on critical ingredients from China and can be the spark plug to renewed interest in bringing manufacturing back to the U.S.
     
    4. Shrinking price gap. While pharma firms have been saving costs by outsourcing manufacturing to Chinese firms for many years now, they are fast realizing that given the quality concerns, as well as complex importing regulations, the savings are not as great as they should be. In fact, they can be more costly in the long run, when manufacturing has to be repeated or inspections fail. 
     
    5. Growing private-public support. In addition to the coronavirus, rising trade tensions with China are exposing the need for the U.S. to shore up its manufacturing to become less reliant on it for many APIs and materials. We can expect to see many manufacturing facilities in the U.S. getting refurbished and updated with new technology that can help them better compete and bring manufacturing back home. 
     
    For the benefit of both the U.S. and China, there will continue to be a complementary partnership that brings critical drugs to market as affordably and effectively as possible. Recent challenges, however, in terms of work stoppages, quality issues and problems with collaboration, have been an eye-opener for the U.S., and just may be the spark that creates a resurgence of API manufacturing closer to home.
     

    Ed Price is President and CEO of Seqens North America (formerly PCI Synthesis), an integrated global provider of pharmaceutical synthesis and specialty ingredients. From the company’s Newburyport, Mass. operations, Seqens N.A. provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules.
     
     
     

    Related Expert's Opinion

    • Clinical Trials | Information Technology
      Top 5 Things to Know Before Selecting Clinical Trial Technology

      Top 5 Things to Know Before Selecting Clinical Trial Technology

      Look for a future-proof model, innovative vendors - not cutting-edge technology, and focus on user-centered design and interoperability.
      Andres Garcia, Co-founder and CTO Florence 02.08.21

    • Clinical Trials
      The Future of Clinical Trials Series: Part II

      The Future of Clinical Trials Series: Part II

      Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.
      Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable 01.26.21

    • Clinical Trials
      The Future of Clinical Trials Series: Part I

      The Future of Clinical Trials Series: Part I

      What will 2021 have in store for an industry in flux?
      Alison Holland, Head of Decentralized Trials, Medable, Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health 01.19.21


    • Clinical Trials | Drug Development | Information Technology
      Virtual Clinical Trials: The Future of Dermatology Studies

      Virtual Clinical Trials: The Future of Dermatology Studies

      COVID-19 has created lasting impacts for clinical trials and a host of benefits have arisen from the adoption of virtual and hybrid models.
      Sonja VanWye, RN, MSN, Director, Dermatology Strategy, IQVIA Biotech 01.15.21

    • Clinical Trials | Drug Development
      The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs

      The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs

      Appropriate adaptive designs in early stages of development can accelerate timelines and reduce costs, and help focus on the most promising agents.
      Jürgen Hummel, MSc, Senior Director, Statistical Science, PPD, and Lead of PPD’s Adaptive Design Working Group 01.07.21

    • Drug Development | Industry News | Regulatory Affairs
      The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

      The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

      A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
      Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21


    • Cold Chain Management | Logistics
      COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

      COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

      How the air cargo logistics community is embracing technology to close critical gaps in the cold chain.
      Chris Jones, EVP, Marketing and Services, Descartes 12.15.20

    • Clinical Trials | Information Technology
      Life Sciences Strive for Greater Agility

      Life Sciences Strive for Greater Agility

      Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.
      Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA 12.14.20

    • Clinical Trials | Drug Development | Information Technology
      Advances in Intelligent Automation

      Advances in Intelligent Automation

      The future of medicine relies on further digital transformation and automation-enabling solutions to improve drug development and monitoring.
      Updesh Dosanjh, Practice Leader, Technology Solutions, IQVIA 12.14.20


    • Drug Development
      Navigating Uncertainty: Considerations for Life Sciences 2021

      Navigating Uncertainty: Considerations for Life Sciences 2021

      With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
      Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP 12.11.20

    • Information Technology | Supply Chain
      The Pandemic & The Pharma Industry: 3 Things to Know

      The Pandemic & The Pharma Industry: 3 Things to Know

      The importance of vendor contract visibility, an increase in intense legal scrutiny, and new technology for greater agility and control.
      Colin Earl, CTO at Agiloft 11.16.20

    • Clinical Trials | Information Technology
      AI and Advanced Analytics

      AI and Advanced Analytics

      Equipped with the right tools, CROs are better positioned to develop optimal protocols, rapidly identify patients to enroll, and preempt study issues.
      Paul Oliver, Medidata 11.13.20


    • Clinical Trials | Information Technology
      eCOA: Addressing Barriers to Faster Deployment in Clinical Trials

      eCOA: Addressing Barriers to Faster Deployment in Clinical Trials

      Clinical Outcome Assessments are an increasingly important tool in clinical research.
      Paul O'Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata 11.13.20

    • Preparing to Adopt Intelligent Label Management

      Preparing to Adopt Intelligent Label Management

      The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
      Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA 11.13.20

    • Biologics, Proteins, Vaccines | Cold Chain Management | Logistics | Supply Chain
      Rising to The Occasion: The High Stakes of Vaccine Transport

      Rising to The Occasion: The High Stakes of Vaccine Transport

      How logistical precision can ensure safe and efficient delivery of the COVID-19 vaccine.
      Bill Brooks, Vice President of North America Transportation Portfolio at Capgemini 11.04.20

    Trending
    • Catalent Acquires Delphi Genetics
    • BMS Expands Cell Therapy Manufacturing Capabilities
    • AbbVie Opts To Acquire Mitokinin
    • Four Female Leaders Appointed To Cell & Gene CDMO
    • WuXi AppTec Completes OXGENE Acquisition
    Breaking News
    • Amgen to Acquire Five Prime Therapeutics for $1.9B
    • Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    • CureVac, Novartis Ink COVID Vax Mfg. Pact
    • Innoforce and dMed Enter Development Collaboration
    • Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Hygienic Packaging Technology
    • Trends in Solid Oral Dosage Delivery
    • 5 Reasons Paper Has No Place in Contract Manufacturing
    • Injectable Drug Delivery Trends
    • Pharmaceutical Manufacturing Equipment Trends
    • Oral Solids: Market & Technology Trends
    • Nutraceutical Manufacturing: Meeting the Challenges of Today, Planning for Tomorrow
    • 2021 Contract Manufacturing Survey
    • Small Molecule Development Trends
    • Challenges & Opportunities Facing Small & Emerging Biopharma Companies
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Statins May Contribute to Vascular Calcification by Inhibiting Vitamin K-Dependent Proteins
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    Maroon Group Acquires Cary Company's Raw Materials, Specialty Chemicals Distribution Business
    Matt Fogel Named Mule-Hide's Territory Manager – Southern Virginia
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Expands Its Kosmos Hardware Platform
    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Amgen to Acquire Five Prime Therapeutics for $1.9B
    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    CureVac, Novartis Ink COVID Vax Mfg. Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Estée Lauder Establishes Equity and Engagement Center of Excellence
    L'Oreal On How It Will Shape Beauty's Future at Today's Transparency Summit
    C.O. Bigelow Earns Praise as NYC's Oldest Family-Run Apothecary
    Happi

    Latest Breaking News From Happi

    Avon Launches Vegan Skin Care Line
    Inolex Appoints VP Marketing
    Decorté Launches AI Diagnostics in US
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Springfield Solutions highlights digital label embellishments
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Appoints Managing Director, China and Asia Pacific
    Full-Year Sales Down 12 Percent at Zimmer Biomet
    Lincotek Medical Expands Coatings and Additive Capacity
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login