• 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
    Iontas and Fair Journey Biologics Partner with Quell Therapeutics

    Vetter Establishes Office in China

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    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

    Vetter Establishes Office in China

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

    Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark
    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

    Vetter Establishes Office in China

    Data Management Trends

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    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
    Cytovance Biologics

    Baxter BioPharma Solutions

    Alcami

    PCI Pharma Services

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

    Adare Pharma Solutions

    Baxter BioPharma Solutions

    Reed-Lane

    Almac Group
    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
    Breaking News

    Carbogen Amcis API Site Passes FDA PAI

    Completes successful FDA inspection of its Neuland site in Hunzenschwil, Switzerland with no Form 483s

    Carbogen Amcis API Site Passes FDA PAI
    Carbogen Amcis API site passes FDA pre-approval inspection with no Form 483s
    Related CONTENT
    • Mogene
    • Vetio Animal Health
    • CordenPharma Names New CEO
    • AveXis, BIA Ink Gene Therapy Manufacturing Process Development Deal
    • Cytovance Completes Second FDA PAI of Oklahoma Facilities
    08.07.19
    Switzerland-based Carbogen Amcis AG, a pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, said its Hunzenschwil (Neuland), Switzerland API manufacturing site has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection.
     
    The four-day, pre-approval inspection was undertaken by an FDA investigator from July 8-11, 2019. The inspection was concluded with no Form 483’s filed, thus confirming that no critical or major observation was raised during the inspection. The auditor will recommend the approval of API for which the audit was conducted. The final Establishment Inspection Report (EIR) is expected within the next six months.
     
    “This latest pre-approval confirms the total commitment to quality and teamwork of each of our colleagues working across the entire company,” said Mark Griffiths, chief executive officer, Dishman Carbogen Amcis Group. “Our team successfully completed the audit with the best possible result, thus ensuring our Client can progress towards bringing an important new treatment to patients.”
     
    Martin Schneider, chief quality officer at Carbogen Amcis, said, “This result is a continuation of a series of positive inspections across CARBOGEN AMCIS, reinforcing our successful history of regular FDA (11), Swissmedic (each Swiss site inspected every 2-3 years), Korean FDA (2) and ANSM (2) audits.”
     
    The Hunzenschwil facility is one of Carbogen Amcis’ four sites to offer development and manufacturing facilities for highly potent compounds. It manufactures products according to cGMP standards and is routinely inspected by Swissmedic, the FDA and external customers. Located in the district of Lenzburg in the canton of Aargau 25 km west of Zurich, the manufacturing site was opened in 2000.
    Related Searches
    • pre-approval inspection
    • quality
    • chief executive officer
    • fda
    Suggested For You
    Mogene Mogene
    Vetio Animal Health Vetio Animal Health
    CordenPharma Names New CEO CordenPharma Names New CEO
    AveXis, BIA Ink Gene Therapy Manufacturing Process Development Deal AveXis, BIA Ink Gene Therapy Manufacturing Process Development Deal
    Cytovance Completes Second FDA PAI of Oklahoma Facilities Cytovance Completes Second FDA PAI of Oklahoma Facilities
    Serialization and the Rest of Us Serialization and the Rest of Us
    FDA Inspection of Asymchem Dunhua 1 API Manufacturing Facility is Successful FDA Inspection of Asymchem Dunhua 1 API Manufacturing Facility is Successful
    Tedor, Adial Enter Manufacturing Collaboration Tedor, Adial Enter Manufacturing Collaboration
    FDA Approves TraceLink DSCSA Pilot Submission for Network Solutions FDA Approves TraceLink DSCSA Pilot Submission for Network Solutions
    Nitrosamines Nitrosamines
    Process Validation in Biologics Development Process Validation in Biologics Development
    Swissfillon Completes Successful FDA Inspection Swissfillon Completes Successful FDA Inspection
    Dalton Pharma Services Completes PAI Inspection Dalton Pharma Services Completes PAI Inspection
    AGC Biologics CEO to Step Down AGC Biologics CEO to Step Down
    Myoderm Announces Leadership Transition Myoderm Announces Leadership Transition

    Related Breaking News

    • Breaking News | Collaborations & Alliances
      Iontas and Fair Journey Biologics Partner with Quell Therapeutics

      Iontas and Fair Journey Biologics Partner with Quell Therapeutics

      Novel target binders from Iontas/FJB will be used to uncover functional antibodies to advance Quell’s engineered Treg cell therapy pipeline.
      Charles Sternberg, Assistant Editor 03.08.21

    • Breaking News | cGMP Manufacture | Drug Development | Industry News
      Vetter Establishes Office in China

      Vetter Establishes Office in China

      Additional office in Asia Pacific region to promote development of new business in China.
      Kristin Brooks 03.08.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      AGC Biologics Expands Cell and Gene Facility in Italy

      AGC Biologics Expands Cell and Gene Facility in Italy

      Plans call for increased capacities and viral vector suspension capabilities at Milan site.
      Tim Wright, Editor, Contract Pharma 03.05.21


    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      Celonic to Boost Cell & Gene Therapy Production

      Celonic to Boost Cell & Gene Therapy Production

      Will establish a new facility in the upcoming Life Science Park Rheintal in Stein, Switzerland.
      Tim Wright, Editor, Contract Pharma 03.05.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

      Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

      Continues to build integrated capabilities platform for cell and gene therapy.
      Tim Wright, Editor, Contract Pharma 03.05.21

    • Breaking News | Collaborations & Alliances | Drug Delivery | Industry News
      Aptamer Extends Collaboration with AstraZeneca

      Aptamer Extends Collaboration with AstraZeneca

      Will continue to explore next-generation drug delivery approaches.
      Tim Wright, Editor, Contract Pharma 03.05.21


    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark

      Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark

      Virtual ground-breaking ceremony celebrates initiation of expansion to double cell culture capacity and add large scale fill/finish capabilities.
      Tim Wright, Editor, Contract Pharma 03.05.21

    • Breaking News | Industry News
      Amgen to Acquire Five Prime Therapeutics for $1.9B

      Amgen to Acquire Five Prime Therapeutics for $1.9B

      Adds Five Prime's pipeline of immuno-oncology and targeted cancer therapies to Amgen's oncology portfolio.
      Kristin Brooks 03.04.21

    • Bioanalytical Services | Breaking News
      Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions

      Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions

      Adds ‘off the shelf’ PK profiling capabilities to its portfolio.
      Charles Sternberg, Assistant Editor 03.04.21


    • Breaking News | cGMP Manufacture | Industry News | Scale-up/Technology Transfer
      CureVac, Novartis Ink COVID Vax Mfg. Pact

      CureVac, Novartis Ink COVID Vax Mfg. Pact

      Novartis to manufacture the mRNA and bulk drug product of the CVnCoV vaccine for up to 50 million doses by the end of 2021.
      Kristin Brooks 03.04.21

    • Bio News | Breaking News | Collaborations & Alliances | CRO News | Drug Development | Drug Discovery | Industry News | R&D
      Innoforce and dMed Enter Development Collaboration

      Innoforce and dMed Enter Development Collaboration

      Aims to accelerate the development of innovative therapeutics.
      Tim Wright, Editor, Contract Pharma 03.03.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

      Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

      New 25,000 sq. ft. GMP facility located College Station, TX.
      Tim Wright, Editor, Contract Pharma 03.03.21


    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Promotions & Moves
      Four Female Leaders Appointed to Cell & Gene CDMO

      Four Female Leaders Appointed to Cell & Gene CDMO

      The Center for Breakthrough Medicines makes leadership appointments to fuel company growth.
      Tim Wright, Editor, Contract Pharma 03.03.21

    • Breaking News
      Fusion Pharmaceuticals Acquires IPN-1087

      Fusion Pharmaceuticals Acquires IPN-1087

      Expands its pipeline of potent alpha-emitting radiopharmaceuticals.
      Charles Sternberg, Assistant Editor 03.02.21

    • Breaking News | Clinical Trials
      Strata Oncology Unveils Strata PATH Trial

      Strata Oncology Unveils Strata PATH Trial

      The new platform clinical trial will evaluate FDA-approved therapies in novel biomarker profiles learned from real-world data.
      Charles Sternberg, Assistant Editor 03.02.21

    Trending
    • Four Female Leaders Appointed To Cell & Gene CDMO
    • BMS Expands Cell Therapy Manufacturing Capabilities
    • Reed-Lane Facility Virtual Tour
    Breaking News
    • Jubilant Therapeutics Appoints Chief Scientific Officer
    • Iontas and Fair Journey Biologics Partner with Quell Therapeutics
    • Vetter Establishes Office in China
    • AGC Biologics Expands Cell and Gene Facility in Italy
    • Celonic to Boost Cell & Gene Therapy Production
    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

    Thymoquinone Inhibits Viral Infection in In Vitro Settings, New Study Finds
    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Coatings World

    Latest Breaking News From Coatings World

    Sherwin-Williams Announces Resignation of President, COO
    Ashland Completes Expansion, Relocation of Viatel Bioresorbable Polymers Manufacturing Facility
    Evonik Receives Sustainability Award from EcoVadis
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Avacta’s Rapid Antigen Test Proves Effective for New Coronavirus Variants
    Cretex CFO Announces Retirement
    New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Jubilant Therapeutics Appoints Chief Scientific Officer
    Iontas and Fair Journey Biologics Partner with Quell Therapeutics
    Vetter Establishes Office in China
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    e.l.f. Cosmetics and Chipotle Collaborate on Burrito-Inspired Makeup Collection
    Weekly Recap: Sephora Expansion, Ulta Partners with Loop, International Women’s Day & More
    Ulta Beauty Opens in Herald Square
    Happi

    Latest Breaking News From Happi

    Batiste Rolls Out Wonder Woman Dry Shampoo
    Erno Laszlo Taps Carina Lau as Global Spokesperson
    It's International Women's Day
    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

    Epson reveals new ink for ColorWorks C6000-Series label printers
    VPF launches liner made from recycled paper
    Cartes engineers inkjet embellishment technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Names Chief Research and Development Officer
    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Colfax Decides to Divide Its Businesses
    Stryker Corp.'s 2020 Sales Slip 3.6 Percent
    Bioventus Appoints Managing Director, China and Asia Pacific
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

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

    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