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

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 formulation development and manufacturing. We have the quality you insist upon in a contract development partner.

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 US Food and Drug Administration and has been assigned a unique establishment registration number.
  • The Indiana Department of Health.
  • 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)
  • 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)

• • • 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)
    • 5th Inspection: January 2011 : No 483 issued
    • 6th Inspection: December 2011 : 1 minor observation (satisfactory response was submitted promptly)
    • 7th Inspection: February 2012 (pre-approval inspection for NDA) : No 483 and approval granted
    • 8th Inspection: May 2015 : No 483 issued
    • 9th Inspection: Nov 2017:  1 minor observation (satisfactory response was submitted promptly)
    • 10th Inspection: Feb 2021 (Remote): No 483 issued