Call (973) 276-0740

Granulation Technology, Inc. is a chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is a FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA Registered to handle Class III - V controlled subtances. We have been consistently adding to our large list of clientele ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach insures high quality products while providing cost competitive advantages.

Product Development

Granulation Technology, Inc. functions with a goal to deliver product development solutions that enhance the drug development portfolio. We offer following key services:

  •  Pre-formulation studies
  •  Pharmacovigilance
  •  Quality by design
  •  API evaluation
  •  Process optimization studies
  •  Bio studies management
  •  Feasibility studies
Product Development
Formulation Development
Formulation

With a diverse team of experienced scientific professionals, we can be a partner of choice for diverse drug products, including various dosage forms as listed below:

  •  Immediate & controlled release oral solid dosage forms
  •  Powders
Analytical Development

We have capabilities to carry out the following analytical development activities in addition to method validations, which adhere to highest quality standards and regulatory compliance:

  •  Analytical Method Development & Method Validations
  •  Forced degradation studies
  •  Cleaning method
  •  Stability studies
  •  Dissolution and drug release profiling
  •  Raw material and packaging material testing
  •  Stability monitoring as per ICH guidelines
  •  Release testing and particle size analysis
Analytical Development
Our Manufacturing
Manufacturing

Our FDA GDUFA listed facilities are proficient at carrying out the following manufacturing technologies:

  •  Wet & Dry Granulations
  •  Encapsulation
  •  Capsule Banding
  •  Blending
  •  Tableting (Compression)
  •  Film coating
  •  Packaging of Tablets and Powders
  •  Pouching/Blister Packaging
We're not the only ones excited about GTI...
Certified By:
FDA Approved
Mnufactured to cGMP Standards
International Organization for Standardization ISO 9001
Kosher
Halal
U.S. Justice Department Drug Enforcement Administration