A leading Contract Research Organization (CRO) and a full service cGMP certified manufacturer, KP Pharmaceutical Technology, Inc. (KPPT), a privately held corporation, started operations in 1997 in Bloomington, IN.

At KPPT, we have dedicated manufacturing areas with independent HEPA/HVAC air handling and dust containment systems. We also have a complete in-house, independent QC Laboratory fully equipped with all modern analytical instrumentation required for raw material and finished product release testing and stability studies as per cGMP and ICH guidelines. We have the capability for developing and manufacturing oral, topical as well as sterile dosage forms. Our qualified state-of-the-art, sterile / aseptic fill and finish manufacturing facility with class 100 clean rooms can manufacture and test all types of parenteral (sterile) dosage forms, including lyophilized formulations. Terminal sterilization can also be performed if required.

Our facility is one of only a few centers to offer the range and scope of services needed by commercial clients. We work closely with clients to develop and produce virtually every type of pharmaceutical dosage form. We partner with large and small pharmaceutical firms from around the world to develop and produce new pharmaceutical agents for use in human clinical trials as well as commercial manufacturing.

cGMP Facility

At KPPT, we employ state-of-the-art technologies and systems that are up to date and comply with the regulations mandated by the Federal Code of Regulations (USA). We have a complete in-house QC Laboratory fully equipped with all modern analytical instrumentation required for raw material and finished product release testing as well as stability studies as per cGMP and ICH guidelines.

Quality Assurance and Quality Control

With over 20 years’ experience developing, manufacturing and testing pharmaceuticals for major pharmaceutical and research organizations, KP's principals and support staff have very extensive scientific background and expertise. The combined experience, knowledge and troubleshooting capabilities give KP one of the most outstanding product development teams in the industry.

KP can provide all of the services required for ANDA submissions, the CMC sections of an IND submission, and NDA support and development. Testing is done to provide our clients with the most rapid turn-around, the most thorough documentation, and the greatest cost-effectiveness possible.

KP is a company dedicated to scientific excellence in drug development and manufacturing. We have the quality you insist upon in a contract development partner.

Registrations and Licenses

KP Pharmaceutical Technology, Inc., (KPPT) is a pharmaceutical contract manufacturing and research and development organization registered with the US-Food and Drug Administration (US-FDA). All products are manufactured in compliance with the current Good Manufacturing Practices as set forth in the code of the federal regulations (CFR), section 21 parts 210 and 211. Current standard operating procedures shall be followed during all manufacturing and testing processes.

KPPT is registered with the:

1. The US Food and Drug Administration and has been assigned a unique establishment registration number.
2. The Indiana Department of Health.
3. KP Pharmaceutical Technology, Inc., is registered and inspected by the State of Indiana to handle Schedule 2, 2N, 3, 3N, 4 and 5 controlled substances. This “Researcher” DEA Registration Number is (available upon request)
4. KP Pharmaceutical Technology, Inc., is registered and inspected by the State of Indiana to manufacture Schedule 2 & 3 controlled substances. The “Manufacturer” DEA Registration Number is (available upon request)

FDA Inspections

• 1st Inspection: September 2001 : No 483 issued
• 2nd Inspection: July 2003 : No 483 issued
• 3rd Inspection: February 2005 : No 483 issued
• 4th Inspection: September 2009 : 1 minor observation (satisfactory response was submitted promptly)