Hledán partner pro průmyslovou výrobu granulátu vitamínu B1 a / nebo vitamínu B6 podle GMP standardů

Francouzské technické centrum specializující se na jemnou chemii hledá farmaceutické organizace na smluvní výrobu (SOT - Contract Manufacturing Organization) s certifikací (GMP - Good Manufacturing Practice) granulátu prášku vitamínu B1 a B6 za použití fluidních sprejů a následného sušícího procesu s využitím hydroxypropylmethyl celulózy (HPMC)jako pojiva. Konečné vyrobené prášky budou využity pro přímou kompresi tablet. Francouzské technické centrum hledá partnera pro technickou spolupráci a sepsání výrobní dohody.

Description:

A French technical centre specialized in Fine Chemistry needs to granulate B1 and/or B6 vitamins. The granulation of powders must be operated thanks to a fluidized-bed spray-drying granulator. The powders are suspended in the heated air of the fluid bed and the liquid binder sprayed from nozzles positioned above. The Hydropropylmethyl cellulose (HPMC) solution is sprayed onto the vitamin powders in a fluidized-bed spray-drying equipment in order to produce powders for direct compression of medicine tablets.

The CMO should produce 1000kg of B1 vitamin powder and 200kg of B6 vitamin powder each year. The size of the batches has to be defined by the CMO regarding its own available equipment. The CMO should realize the manufacturing of 2 batches of each vitamin for the registration.

The raw material will be provided before treatment to the CMO. The powders will be processed and then packaged and shipped back to France by the CMO. The French technical centre seeks partner for Technical cooperation and Manufacturing agreement.
Technical Specifications / Specific technical requirements of the request

The CMO should:
-be equipped with a fluid bed spray/drying granulator at industrial scale.
-be a GMP certified company,
-produce two batches for testing and registration,
-manufacture granulated powder: 1000kg/year of B1 vitamin and 200kg/year of B6 vitamin (for use in direct compression of tablets).

The final produced powders should be composed of vitamin (97%) and HPMC (3%).
Current and Potential Domain of Application

Chemical powder treatment for pharmaceutical industry
Other Profile Details

List of Keywords
Technology

* Coatings
* Drying
* Mixing (powder, etc.), separation (sorting, filtering)
* Pharmaceutics
* Special chemicals, intermediates

Market
Organisation/Company
Type: Technical Centre/Technology transfer Centre
Size: <10
Collaboration Type

* Adaptation to specific needs
* Transfer of knowledge in new raw materials
* New way to use an existing production line


Comments
- Type of partner sought:
Contract Manufacturing Organization with GMP Standards

- Specific area of activity of the partner:
Fine Chemistry - Chemical technology and engineering

- Task to be performed by the partner sought:
-To produce two batches for testing and registration,
-To manufacture 1000kg/year of granulated B1 vitamin direct compression powder and 200kg/year of granulated B6 vitamin direct compression powder.

Ref: 12 FR 34K2 3OKU

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