At KPPT we have a line of modern and up-to-date equipment and over 60,000 sq.ft of cGMP facilities to meet your R&D, Analytical and all manufacturing requirements in a rapid and cost efficient way. Every part of the project is handled in-house maintaining stringent quality standards.
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.
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
For an updated list of equipment and instruments in our facility contact firstname.lastname@example.org