Dedicated to Scientific Excellence

cGMP Drug Development from Preclinical through Commercial Manufacturing
Your trusted partner for quality and reliability

A leading Contract Development and Manufacturing Organization (CDMO) providing specialized pharmaceutical services since 1997

27+ Years of Excellence
100+ Years Combined Experience
FDA Registered & Inspected
DEA Registered & Inspected
EU cGMP Compliant

Your One-Stop Shop for Quality and Reliability

KP Pharmaceutical Technology, Inc. is committed to providing its industry clients with an unparalleled combination of expertise, support, and services to augment and accelerate their pharmaceutical development, regulatory approval, and commercialization pathway to the market.

With over 100 years in combined professional experience and successfully developing and manufacturing several hundred drug products, at KPPT, you are with the best development partner for a quality product and fastest turnaround in the industry today.

Comprehensive CDMO Services

Preformulation Studies

Providing you a realistic insight into your API's quickest pathway to a successful pharmaceutical dosage form.

Formulation Development

World-class formulation development services designed to offer the quickest path to a commercially viable pharmaceutical drug product.

Commercial Manufacturing

Your development partner from pre-clinical through commercial scale drug products with fastest turnaround in the industry.

Clinical Trial Material (CTM)

CTM manufacturing and packaging including double-blinded kits for all kinds of dosage forms.

Stability Testing

Analytical and stability testing of pharmaceuticals as per ICH guidelines with full service analytical methods development and validation.

Packaging Services

Professional packaging solutions including pre-filled syringes, cartridges, and CTM storage with worldwide distribution.

Advanced Manufacturing Capabilities

Our Specialized Services

Aseptic Fill and Finish
Lyophilization
Microfluidization
Powder Filling
Potent / Cytotoxic Compounds
Vaccines & mRNA
PEGylation
Peptides & Monoclonal Antibodies
Liposomes & Lipid Nanoparticles
Pre-Filled Syringes and Autoinjector Cartridges
Sterile Aseptic Powder Filling
Tablets, Capsules, Microdosing

The KPPT Difference

Industry-Leading Compliance

US-FDA Registered and Inspected cGMP Facilities
DEA Registered "Researcher" and "Manufacturer" Facilities
EU (European Union) cGMP Compliant and QP Inspected Facilities
Complete In-House QC Laboratory
Class 100/ISO-5 Certified Clean Rooms
State-of-the-Art cGMP Manufacturing Facilities

State-of-the-Art cGMP Manufacturing

At KPPT we have a line of modern and up-to-date equipment and over 20,000 sq.ft of cGMP facilities supported by over 40,000 sq.ft of operational support space 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.

We employ state-of-the-art technologies and systems that comply with regulations mandated by the Code of Federal Regulations (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.

60,000+
Square Feet of Manufacturing and Support Facilities
100%
In-House Operations

For an updated list of equipment and instruments, contact info@kppt.com

Registrations and Licenses

KP Pharmaceutical Technology is registered and inspected by multiple regulatory bodies:

  • US Food and Drug Administration as a drug product manufacturer
  • Indiana Department of Health
  • DEA for controlled substances scheduled I through V under "Researcher" Registration
  • DEA for controlled substances scheduled II and III under "Manufacturer" Registration
  • EU cGMP Compliant and QP Inspected

FDA Inspection details available upon request

Quality Assurance & Quality Control

With over 25 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.

Regulatory Support

KP can provide integrated CMC development support and regulatory documentation support for ANDA, NDA, and IND submissions.

Testing Services

Testing is done to provide our clients with the most rapid turn-around, the most thorough documentation, and the greatest cost-effectiveness possible.

Scientific Excellence

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.

Our People

Dr. Rajinder (Raj) Matharu

President and Chief Executive Officer

Dr. Matharu has a Masters and a Ph.D. degree, as well as significant post doctoral research experience in pharmaceutical sciences specializing in the development, manufacturing and testing of novel drug delivery systems including controlled release formulations.

Dr. Matharu is well versed in drug development and production technology, as well as pharmaceutical quality control. He has served as the Principal Investigator on several industrial and NIH pharmaceutical R&D and manufacturing contracts and has co-authored a number of publications/presentations as well as international patents.

Dr. Matharu is supported by a team of highly qualified and well trained scientists and technicians to assist in all the research, manufacturing and quality control/quality assurance operations of the company.

Company organization chart available upon request

Expert Advisors

From time to time we use advisors and outside consultants. The advisors to KP are all internationally recognized experts and have a long and very close relationship with the Company's principals.

For a list of current advisors and experts please contact Dr. Matharu

Join Our Team

Explore exciting career opportunities at KPPT

Let's Discuss Your Project

We are a reliable, market-driven company that understands the necessity of cost-effective R&D and production of highly time-sensitive clinical supplies. All projects are executed under complete confidentiality, client specific needs and in compliance with cGMP.