sourcing center

From the moment a drug, biologic, or consumer health product is just a good idea in your mind to the moment it reaches the pharmacy shelf, Catalent can help you.

From drug and biologic development services to delivery technology and supply solutions, we’ve been the catalyst for the success of thousands of innovators, both large and small, in over 100 markets. With nearly 30 fully integrated global sites that make or package over 100 billion units annually, we are fully committed to partnering with you to ensure the highest quality product, within your budget and timeline, under the strictest global compliance.  

To make your search for a stable, reliable collaborator easier, we’ve created this virtual RFP – a resource where we can start to answer questions on our business to inform your business decisions. Whether you are looking for a single, tailored solution or multiple answers throughout your product’s lifecycle, we’ll show you how we can get your products to market faster, stay there longer, and be more successful.  Consult with us for a follow up or contact us for more specific details. 

General Business Information
  • Company's legal name: Catalent Pharma Solutions, LLC
  • CEO: John Chiminski, President and CEO
  • Director of Global Accounts: Will Downie
    sales@catalent.com
    Spun off from Cardinal Health in April 2007, Pharmaceutical Technologies and Services (PTS) was purchased by The Blackstone Group and renamed Catalent Pharma Solutions. For more details, see Our History.
  • Parent entity: The Blackstone Group
  • Company address & phone: 
    14 Schoolhouse Road 
    Somerset, NJ 08873 
    +1 866-720-3148 (phone)
    +1 732-537-6480 (fax)
  • Email: info@catalent.com
  • Website: www.catalent.com
Scope
Number of sites

28 sites on 5 continents.
View detailed information on each of our sites

Major Business Units
Locations by expertise
  • Development & Clinical Services
    • Research Triangle Park, North Carolina
    • Philadelphia, PA
    • Schorndorf, Germany
    • Bolton, UK
  • Integrated Packaging Services
    • Schorndorf, Germany
    • St. Petersburg, FL
    • Swindon, United Kingdom
    • Woodstock, IL
  • Oral Solids Development & Manufacturing
    • Winchester, KY
    • Somerset, NJ
    • Schorndorf, Germany
    • Swindon, UK
  • Softgel Development & Manufacturing
    • St. Petersburg, FL
    • Somerset, NJ
    • Beinheim, France
    • Swindon, UK
    • Eberbach, Germany
    • Aprilia, Italy
    • Kakegawa, Japan
    • Buenos Aires, Argentina
    • Braeside, Australia
    • Sorocaba, Brazil
  • Sterile Manufacturing
    • Woodstock, IL
    • Brussels, Belgium
    • Schorndorf, Germany
    • Limoges, France

All sites within the groupings have overlapping and complimentary capabilities, serving to further enhance Catalent's ability to successfully provide services globally. All Catalent sites have corporate oversight and harmonize their methodologies across Project Management, Quality, and Operations. Functional excellence is strongly emphasized. Typically each site employs project management trained professionals and quality auditors who handle a specific number of projects and are capable of handling projects across multiple Catalent sites.

Sterile Manufacturing

From drug and biologic-development services to delivery technologies to supply solutions, Catalent offers a broad range of services, including clinical and manufacturing, analytical support, secondary packaging, and stability. We also offer cutting-edge oral, sterile, and inhalation technologies. Catalent has 25 years experience in blow/fill/seal manufacturing of sterile pharmaceuticals, including combination products and complex formulation and sterilization processes. We also have experience launching and manufacturing ophthalmic products.

  • Most complete fiscal year
    • July 1, 2008 - June 30, 2009 (FY09)
  • Total revenue for services
    • FY07: $112 million
    • FY08: $124 million
    • FY09: $139 million
  • Sales for the three most recent fiscal years
    • FY07: $1,694.0 million
    • FY08: $1,817.7 million
    • FY09: $1,639.5 million
    • FY10: $1,702.6 million
  • Percentage of revenues derived from business units
    • Oral technologies 56%
    • Sterile Technologies 17%
    • Packaging Services 27%
  • Scope of production
    • Catalent only manufactures products on a contract basis for customers.
  • Number of employees
    • 9,200
  • Number of scientists
    • Over 1,000
  • Number of patents
    • Over 1,200 patents and patent applications.
  • Number of unique technology platforms
    • 9

Please contact us if you require more detailed information on revenue for services.

Procedures
Fees

Fee and payment terms will be outlined in your specific proposal. Catalent strives to meet your business needs with flexible business models.

Formal project management systems

Catalent understand the need for projects to run smoothly, stay within budget, and arrive at market reliably and on time. Managing across the entire lifecycle of your product, we use operational Excellence Lean Six Sigma principles to streamline communications to a single point of contact and maximize production to create a more flexible, direct route to market. With our technological innovations, expert teams, and advanced equipment, we help save you time and money by maximizing your product’s benefits early in development and thus speed your path to market. Backed by an interconnecting network of global facilities and standardization of policies and agreements, we are able to supply you with the highest quality of goods and services at any stage of development, anywhere in the world – even with late-stage customization.

Procurance of raw materials and components

Catalent’s customers typically supply active pharmaceutical ingredients. Catalent can procure other materials if required.

Current operating hours

Most facilities operate 5 days per week, up to three shifts per day, weekends as required

Scheduling

Catalent must receive a signed quotation, a signed protocol and all raw materials/intermediates/final product samples in order for a project to be scheduled.

Lead time and timing of forecasts

Our commercial process calls for a rolling forecast to be provided on a monthly basis, with a firm forecast period of 3-4 months; pre-commercial manufacturing lead times are project dependent.

Site management of technology transfer

Our new product development organization contains a sub-team responsible for tech transfer activities. A program manager coordinates a cross-functional team (technical operations, operations, quality) to manage tech transfer activities. Each product goes through a defined technical review process before moving to commercialization.

Compliance

In our position as the #1 Drug Development, Delivery and Supply Partner for the global pharmaceutical and biotech industries we work everyday to provide the broadest range of solutions with excellence in global regulatory compliance and quality management.  As a leading global provider with 24 facilities and a broad range of services and technologies, we maintain a comprehensive assurance and compliance strategy that is continuously reviewed by internal audit teams, regulators, and our customers.

Our focus and disciplined operating mechanisms around everyday inspection readiness has proven itself. In more than fifty of the regulatory inspections that occurred globally across the Catalent network in the last 12 month period we have achieved:

  • Zero critical observations
  • Zero observations of any kind in half of the inspections
  • Average observation rate 70% better than industry average

Here at Catalent we employ a robust process for partnering with our customers which includes a transparent quality management system (QMS) program, pro-active customer outreach, and participation in establishing future standards within our industry.

Regulatory approvals obtained

FDA, MHRA, and authorities from a variety of countries in Asia, South America, Australia, etc.

Government inspections in last five years
  • August 2003 FDA inspection-NAI (No Observations)
  • April 2004 FDA Inspection-CBE30 (No Observations)
  • August 2004 AFSSAPS-GMP Inspection (13 Deficiencies)
  • August 2004 MHRA-Gmp Inspection (17 Observations)
  • August 2004 FDA-GMP Inspection (9 Observations)
  • March 2005 ISO Certification Assessment (No Observations)
  • January 2006 Mexican Authorities GMP Inspection (No Observations)
  • February 2006 Team Biologics-GMP Inspection (4 Observations)
  • April 2006 FDA Directed Inspection (No Observations)
  • April 2006 ISO Certification Assessment (No Observations)
  • March 2007 FDA-GMP Inspection (11 Observations)
  • April 2007 ISO Certification Assessment (6 Observations)
  • August 2007 MHRA-GMP Inspection (12 Observations)
Feedback
Measuring performance

We track key service and quality metrics (e.g., on-time delivery, BRNRFT, etc.), which are reviewed in regular update meetings (generally quarterly) to identify areas for improvement.

Formal customer complaint resolution process

A corporate quality policy is in place for complaint resolution along with site SOPs that can be reviewed at an audit.

Environmental Safety
Environmental licenses

We have received all required environmental licenses.

Disposal of wastes

Waste is disposed of in accordance with all local and federal/national regulations.

Fire standards

All facilities globally meet local fire protection standards. Facility diagrams by site can be provided during audit.

Chemical protection

Many of our facilities have industrial hygiene programs in place; other facilities are in process of gathering IH data. We also have a safety-training program for employees.

Insurance
Facility coverage

We have a $300M property program underwritten by 3 carriers with different levels of participation. Our lead property underwriter is Chartis (formerly AIG/AIU) followed by Star Tech and Munich Re. Catalent employs a property loss control program (engineering services) for all covered locations, and site visits are prioritized on an annual basis.

Workmen’s compensation

Catalent carries Workmen’s Compensation insurance with state statutory limits and a $500k deductible. We also carry U.S. General Liability insurance with a $2M each occurrence limit and a $4M general aggregate limit with a $100k deductible.

Loss prevention

Third-party loss prevention engineering assessments are conducted by Starr's Technical Risk Agency and FM Global annually.

Supplier Diversity
Approach

We are firmly committed to supporting diversity within our supplier base. For more details see Supplier Diversity.