Pharma-Grade Excipients

PharmaPure™ / Pharma-Grade Excipients

To meet the specific needs of the pharmaceutical industry, we offer you excipients that satisfy all the relevant regulatory requirements. PharmaPure™ are primarily oleochemical-derived pharmaceutical-grade excipients such as specialty esters, fatty alcohols, ethoxylates, hard fats, stearic acids, mono- and triglycerides, castor oil derivatives. As a major manufacturer Hi-Tech Pharmaceuticals,Inc. realized the need for premium excipients such as:MCC (MicroTab), Hydroxypropyl Methylcellulose Cellulose (HyproCel™), Granulated Dextrose(PharmaDex™), Dicalcium Phosphate,USP, Dihydrate Unmilled(Ditab™), Sodium Starch Glycolate(Xplode-SSG™), Croscarmellose Sodium(Xplode-CS™), Lactose Monohydrate (LactoTab™) and the exclusive EasyTab™ which is revolutionizing the tablet market due to its ability to direct compress dietary supplements without the need for wet or dry granulation! EasyTab™ is a proprietary Tri-Matrix of granulated and non-granulated binders at precise ratios. EasyTab™ also has a precise ratio of different tapped densities for excellent flowability and excellent compressibility for reproducible tablet weights. EasyTab™ has porous configuration and low dusting. EasyTab™ is a unique product containing monohydrate dextrose, maltodextrin,dicalcium phosphate dihydrate,and microcrystalline cellulose in precise ratios and is designed for direct compression tableting applications. We at Hi-Tech Pharmaceuticals, Inc. are dedicated to research, development and refinement of high quality organic fibres made of plant raw material, including products on cellulose, vegetables or wood fibres designed to the finest fibres, compounds, granulates, mixtures or special formulations.

With our fibre products we provide solutions for various applications and chemical processes for almost every field of daily life, i.e. for pharmaceutical and food applications, or for technical and industrial use.

Hi-Tech's world-wide business structure provides access to a diversity of quality raw materials. This is an important requirement for manufacturing a variety of unique products.

Derived from renewable resources, our fibers provide ecological product choices for our customers. Hi-Tech carries one of the most diverse lines of excipients in the industry and Hi-Tech's quality has always been at the forefront of the industry. Hi-Tech is a manufacturer of all its own excipients and not a middle-man or broker. This ensures we always have stock and our prices are cheaper than our competitors.

Hi-Tech Pharmaceuticals excipients are used by pharmaceutical companies in their topical, oral, parenteral and other formulations as:

  • tableting aids
  • lubricants
  • solubilizers & solvents
  • drug delivery agents
  • consistency factors
  • emulsifiers
  • emollients
  • cream bases
  • suppository masses
  • moisturizers
  • surfactants

for solid, semi-solid and liquid pharmaceutical dosage forms. We are also able to produce customized excipients. Thanks to our excellent and constant product quality and process integrity, Hi-Tech enhances safety right down the line.

PharmaPure™ satisfies the most stringent requirements and complies with the latest pharmacopoeias.

We maintain our high standards through integrated quality management to ISO 9001, ISO 14001 and IPEC – PQG GMP. Our quality system defines in detail the production procedures for our excipients and monitors compliance with the relevant guidelines.

PharmaPure™ with IPEC – PQG GMP Conformity Declaration

We obtained a conformity declaration for IPEC – PQG Good Manufacturing Practices for pharmaceutical excipients in 2009. This sets strict benchmarks in the areas of training and hygiene, pest control, cleaning of production equipment, documentation of individual process steps, traceability of intermediate products and raw materials, and supplier auditing. This saves our customers from having to carry out numerous individual audits.

Extensive purity data

Extensive purity data covering microbiology, aflatoxins, heavy metals, polycyclic aromatic hydrocarbons, etc. as well as USP ingredients are available.

We practice comprehensive quality management to achieve consistently high standards.

Production methods and processes are documented, and finished products are subjected to intensive testing. Through our equipment and safety-conscious, highly trained employees we comply with relevant regulations. We offer you pharmacopoeia-compliant analytics.

Shipment is made directly by Hi-Tech.

This is how we fulfill our own stringent safety specifications, from raw material and packaging through storage, logistics and delivery.