Regulatory services

Regulatory services
Product Description

Asymchem Laboratories (Tianjin) Co., Ltd offers wide range of manufacturing services which includes regulatory services. They generate the complete cmc data package for regulatory filings including: API synthesis flow chart, process control, raw material acceptance criteria and API specifications , API batch analysis, etc. Contact us for more information.

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Asymchem Laboratories (Tianjin) Co. Ltd

  • CN
  • 2015
    On CPHI since
  • 3
    Certificates
  • 5000+
    Employees
Company types
Contract Service
Manufacturer/Innovator
Primary activities
API Producer
Chemical Development
Contract Manufacturer
Excipients Manufacturer
Intermediates Manufacturer
View company profile
Specifications
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Quality Service; Reputation
  • Supplied from
    United States
More specifications Fewer specifications
Sales Markets
Show more Show less

Asymchem Laboratories (Tianjin) Co. Ltd

  • CN
  • 2015
    On CPHI since
  • 3
    Certificates
  • 5000+
    Employees
Company types
Contract Service
Manufacturer/Innovator
Primary activities
API Producer
Chemical Development
Contract Manufacturer
Excipients Manufacturer
Intermediates Manufacturer
View company profile

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  • APIs & Intermediates

    Product APIs & Intermediates

    We leverage our experience in everything – from R&D to process innovation to navigating the complex global regulatory arena – to help clients efficiently develop and manufacture quality products  • Small Molecules
      • Carbapenems
      • Glycans
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  • Oligonucleotides

    Product Oligonucleotides

    Asymchem’s oligonucleotide technology platform provides clients with full services in drug substance, from process development through GMP manufacturing, and drug product, from preformulation development through fill-finish. The process chemistry, analytical, formulation, and regulations teams collaborate ...
  • Pre-Formulation / Formulation

    Product Pre-Formulation / Formulation

    Asymchem understands that early phase work focuses on learning as much as possible about a drug compound. Our experience across numerous chemical classes and multiple dosage forms, and our ability to develop analytical methods to assess chemical identity, purity, compatibility, and stability, makes us a na...

Asymchem Laboratories (Tianjin) Co. Ltd resources (2)

  • We Are Asymchem

    Brochure We Are Asymchem

  • Service Overview

    Brochure Service Overview

    Driven by curiosity and the desire to break new ground, leading scientists and technologists are attracted to Asymchem’s culture of innovation. It’s a culture built on operational agility and flexibility, a willingness to invest and share risks, and demonstrated expertise in strategic collaboration and partnership.

    Working from this forward-leaning posture, Asymchem successfully supports products at every stage of the lifecycle from preclinical to large-scale manufacturing, with custom development services ranging from investigational new drug (IND) support to Phase III clinical trials and technology transfers for commercial supply.