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
John Chiminski, President and CEO
Director of Global Accounts:
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.
The Blackstone Group
Company address & phone:
14 Schoolhouse Road
Number of sites
28 sites on 5 continents.
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.
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
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.
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:
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
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.
We have received all required environmental licenses.
Disposal of wastes
Waste is disposed of in accordance with all local and federal/national regulations.
All facilities globally meet local fire protection standards. Facility diagrams by site can be provided during audit.
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.
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.
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.
Third-party loss prevention engineering assessments are conducted by Starr's Technical Risk Agency and FM Global annually.