TRADICHEM INDUSTRIAL SERVICES
EU GMP-Certified Pharmaceutical Manufacturing Site At TIS PHARMA, we develop API compaction and granulation processes for third parties to improve production efficiency through our patented...
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About the plant
EU GMP-Certified Pharmaceutical Manufacturing Site
At TIS PHARMA, 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 through our patented technology, Hipering.
After the synthesis or fermentation processes to obtain APIs, many of these active pharmaceutical ingredients require compaction and granulation stages so they can be adjusted to the manufacture of the different final galenic forms. Additionally, many of the APIs need to be pre-compacted when they arrive at drug factories with equipment not specifically designed for this process, with the consequent cost in materials, loss of performance, long lead times and other costs derived from this pre-compaction.
At TIS Pharma, we provide a pharmaceutical service for the physical transformation of raw materials, keeping purity intact, which translates into an increase of up to 60% in operational efficiency for manufacturers of final pharmaceutical forms and the consequent impact on the reduction of industrial costs.
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.
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
Activity
- API PROCESSING manufacturing
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)
- DEA: N/A
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU)
Batch Size / Reactor
- Small, Medium, Large
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
Contact us
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