Process Development Service

Process Development Service
Product Description

Sintenovo, S.A. de C.V. Offers wide range of services which includes process development service. It has capability to support the industrialization of the products in the three continents. Simultaneous chemical and analytical development, scale-up under cgmps, and transfer and validation services, are provided. Core teams are set up for all incoming projects, from evaluation to validation. Business development, ip and regulatory are also involved during the entire development process. “new development concepts”, such as par, qbd, doe, process simulation, etc., are taken into account during development, with special attention paid to the solid form of the final api (particle size, polymorphism). Contact us for more information.

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SINTENOVO, S.A. DE C.V.

  • MX
  • 2015
    On CPHI since
Company types
Manufacturer/Innovator
View company profile
Categories
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Specifications
  • Selling Points
    Quality Service
  • Supplied from
    Spain
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Sales Markets
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SINTENOVO, S.A. DE C.V.

  • MX
  • 2015
    On CPHI since
Company types
Manufacturer/Innovator
View company profile

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    Product Flow Chemistry Service

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SINTENOVO, S.A. DE C.V. resources (1)

  • Brochure

    Sintenovo, SA de CV, Mexican subsidiary of the Spanish Esteve Quimica Group, develops, produces and markets advanced intermediates and APIs for Mexico,US,Europe,Latin America and Asia markets. 
    Sintenovo’s cGMP’s multipurpose plant in Jiutepec has a total capacity of 140 m3 (including hydrogenation and micronization). The last steps of manufacturing are done in clean room areas.

    Our plant has been approved by the Mexican authorities, the European (EMA) and the Japanese (PMDA) health officials. We have been referenced in 2 recent ANDA fillings,expecting the FDA’s inspection in the coming months.