The main source of Pfizer's Active Pharmaceutical Ingredients (API) and Intermediates is the Pfizer's Kalamazoo Active Ingredients (KAPI) facility located in Portage, Michigan USA. Certain materials are also produced by carefully selected Third Party Manufacturers. By leveraging the manufacturing capabilities, quality assurance and synthetic chemical know how, which is the strength of Pfizer, CentreSource is able to supply you with a variety of products with the same "World Class" quality used in Pfizer's own branded products.
The KAPI site is a large, multi-purpose, pharmaceutical chemical and fermentation facility, that covers approximately 56 acres in Portage, Michigan USA. It is the corporation's largest API facility and produces a variety of fine chemicals for use in Pfizer's drug products, as well as CentreSource. The site employs approximately 1,000 people involved in the administration, production, support, and development of API's and intermediates.
To learn more about Pfizer's Fine Chemical Manufacturing capabilities, click on one of the links below:
KAPI Quality Division
API Stability Program
Origin Of Pfizer Steroid Products
Production
Customer Service-Order Processing/Shipping
Special Packaging
Pfizer CentreSource Technical Services
We welcome the opportunity to learn about your pharmaceutical product development needs and challenges. Please contact us to explore how Pfizer's strengths and experience can exceed your goals.
There are over 150 employees within the QC-KAPI organization, including the Analytical Testing Laboratory which tests raw materials and isolated intermediates, the QC Final Release Testing Laboratory, which tests final APIs, and Quality Assurance. The Quality Assurance function assures you that each lot of material from CentreSource meets the highest standards for manufacturing and end product quality. Quality, which is built into the processing, testing and release of each lot of material against recognized standards. These include registered specifications, internal quality targets, and, where appropriate, compendial requirements.
QUALITY ASSURANCE
Our Quality Assurance group is responsible for the testing and release of finished bulk drugs used directly in humans or animals. They are also responsible for internal audits of our Production facility and for investigating process deviations. Established written procedures are followed to assure that components, product containers, closures, in process materials, and finished drug products conform to appropriate standards of identity, strength, quality and purity. Written procedures cover sampling, identification, storage, handling, testing, and documentation of test results. Auxiliary or support activities such as training, calibration, maintenance, stability evaluations, and audits are also described in written procedures.
Written, approved Calibration Procedures are used to assure that equipment and instruments are suitable for their intended functions while in use.
Specifications are designed to assure those individual lots of products and materials released for use meet corporate, regulatory and customer specific requirements within their assigned expiration-dating period.
Quality Control targets are corporate limits for quality characteristics for components and products that should be met per each lot of material received or product manufactured. Thus Pfizer CentreSource (PCS) is committed to providing materials with the highest standard of quality possible. This is important to you, our customer, especially when "Meets USP" is simply not good enough.
Trained personnel (according to our certification program) perform all laboratory testing, which is conducted according to current written, validated, and approved procedures The use of validated analytical procedures assures the accuracy, precision, specificity, sensitivity, ruggedness, and reproducibility of test results. The Laboratory Operation's GMP computer systems are validated. Record checking systems provide verification that the appropriate tests, procedures, and calculations were used and performed correctly and that transcription of data was performed accurately. A trained person other than the analyst who performed the assay performs record checking. Every item essential to the analysis of the material or product is checked. Pfizer uses many of it own in-house reference standards.
A reference standard is a specific batch of a substance of known composition and/or purity to which responses of samples of unknown composition or purity are compared for determining the same. All Pfizer reference standards have been fully characterized and the analytical information obtained is documented. Reference standards are used at their labeled purity and stored according to their label instructions to maintain their integrity. Standards are periodically reviewed and renewed as needed. Also, Pfizer often supplies compendial agencies with material that becomes the official compendial standard, which reinforces the quality of our standards program.
Pfizer places all APIs on a stability program designed to assure the proper quality through the stated shelf life of our products. Samples are stored in packages equivalent to the Pfizer production packages. Samples are stored under conditions consistent with normal production storage practices, the stability Protocol Commitment and/or label storage requirements.
Stability studies for all API's are periodically reviewed and reports are written. Stability reports include a review of the data against current specifications and a regression analysis in order to assess the reassay interval or expiry dating which has been assigned. This system is designed to provide assurance that the most up to date information is made available to CentreSource customers.
The technological basis for providing a broad range of steroid products to the marketplace goes back to the 1950's and our heritage with the former Upjohn Company and G.D. Searle Company. Leveraging this technological heritage, today PCS can deliver a broad range of steroid API's and intermediates.
Pfizer Steroids are derived from what is best described as a semi-synthetic process, using a naturally occurring plant extract as the base raw material. Through a proprietary process involving both chemical and microbiological transformations, Pfizer converts these materials into steroid "building blocks". These "building-blocks", in conjunction with our broad expertise in downstream chemistry, developed over the last 50 years are the bases for the vast array of marketed products we can offer.
Pfizer's Chemical capabilities are second to none in the Pharmaceutical Chemical industry. A broad range of chemistry and technology is used to produce the compounds we supply to the marketplace. The same technological and quality base used for the manufacture of Pfizer branded pharmaceutical products is used for CentreSource's offerings. A partial list of our capabilities is below:
| Oxidations |
Reductions |
Additions & Condensations |
Technology |
| Chromic |
Diisobutylaluminum hydride |
Wittig |
Chromatography |
| Air |
Catalytic hydrogenation |
Grignard |
Resolutions |
| Ozonolyis |
Sodium borohydride |
Mannich |
Aseptic Processing |
| Microbiological |
Chromous & Stannous |
Fluorinations |
Hazardous Reagents |
| Peracid |
 |
Ethynylations |
Particle size Reduction |
| Â |
 |
Cyanations |
 |
| Â |
 |
Radical Additions |
 |
| Â |
 |
Favorskii rearangements |
 |
Thailand, Venezuela, France, California USA, PCS is within reach and can reach you, anywhere on the globe. With sales offices in Singapore, Belgium and Kalamazoo, Michigan USA your orders are received via phone, fax, or mail. Once accepted, the orders are entered into our order processing system and stock is allocated to them. All orders are custom packaged to your specification in the Special Packaging Unit.
After the material has been packaged and labeled, material moves to our shipping unit. Domestic or International our logistics team will put together the proper documentation, for whatever destination together with the goods and speed your shipment on its way. Should you need your documentation sent separately, or to a different location, our team can handle that too.
For International shipments the stock is over packed for export, documents prepared and the shipment turned over to our freight forwarder. Using their global logistics network, your order can be sent via Air Freight, Ground Transport, Ocean Cargo, Courier or a combination. Whatever it takes to put the goods in your hands as quickly as possible. The day following shipment your order can be tracked on the Freight Forwarder's web site, providing valuable information regarding arrival times and customer clearance.
WORLDWIDE LOGISTICS SUPPORT
Another Global Solution from PCS
If "Standard" package sizes for your bulk active or intermediates don't exactly fit your needs or those of your formulation, PCS offers a solution. Our Special Packaging Operations (SPO) stands ready to serve your needs. This area is responsible for the final packaging of our bulk drugs prior to shipment. CentreSource offers a variety of custom package sizes and types designed to meet your manufacturing batch size.
Final packing is performed by a set of skilled operators in HEPA filtered modules designed to minimize both product contamination and worker exposure concerns. Our scales are calibrated frequently and checked several times each day to ensure accurate delivery of quantities ordered. The product is then sealed and labeled and all reconciliation made, prior to order being released to the shipping area for over packing and transport to your location.
Special Packaging - another reason to choose CentreSource as your source for bulk pharmaceuticals.
Product, quality, service, these are the hallmarks of API's from PCS. You see it's not enough to have a world-class manufacturing, quality assurance and logistics support, if they're not accessible to the user. At PCS, we add value to our products by providing a world class team to connect you the customer, with our vast supply network, to provide answers and also ask you the right questions to help you get the most out of the API or intermediate.
Operating from our largest production facility in Kalamazoo, our Technical Development group has the resources readily available to assist you on a global basis. Whether it is reviewing your specification against our quality standards, providing samples, storage, shelf-life or re-test recommendations, product allocation to meet a particular need to arranging for special testing or helping troubleshoot an issue with our material, we're here.
Providing answers, creating solutions, adding value across the globe, that's what CentreSource can provide.