TRADICHEM INDUSTRIAL SERVICES

TRADICHEM INDUSTRIAL SERVICES

HIPERING® TECHNOLOGY - THE GATEWAY FOR LEAN MANUFACTURING

About the plant

EU GMP-Certified Pharmaceutical Manufacturing Site

At TRADICHEM INDUSTRIAL SERVICES, we develop API compaction and granulation processes for third parties to improve production efficiency up to 60% and the consequent impact on the reduction of industrial costs between 40% - 60% through our patented technology: Hipering®.

Hipering® Technology is based on a sequence of processes that improves the physical properties of the starting material keeping its purity and chemical specifications intact.

Hipering® minimizes raw material adhesion, leading to a higher flow rate and reducing active volatility. Also, the density of the APIs is increased obtaining actives suitable for low-volume dosage forms. 

Likewise, our GMP industrial platform allows the control and standardization of batches of raw materials according to the industrial needs of each client; either at the level of the manufacturer of the active ingredient, as well as that of the final pharmaceutical form.

Learn more about Hipering® at: https://hipering.com/

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)

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Activity

• PARTICLE ENGINEERING manufacturing

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Features

• Uses: Commercial (Phase IV), Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• Controlled substance: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Development services, Manufacturing services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Pilot plant, Formulation mixing, Research batches, Scale-up, Pilot batches, Batch records

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