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Chemspec- API

About Chemspec- API

Chemspec-API is an FDA inspected small molecule CMO. Our New Jersey R&D and GMP manufacturing facility is supported by facilities at our parent company, Shanghai Chemspec.

  • Developmental and generic API manufacturing with full CMC support
  • Process R&D. Preclinical, clinical and commercial supplies
  • ISO 7 cleanroom. DEA registration
  • Integrated R&D an
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Certifications
  • FDA
    FDA
  • GMP
    GMP
  • Other
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  • Country/Region:
    United States
  • On CPHI since:
    2023
  • Certificates:
    3
  • Employees:
    1 - 24
Company types
CMO/CDMO
Primary activities
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Generic APIs producer
Regulatory Affairs
Contact info
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Products from Chemspec- API (3)

  • Semaglutide API

    Product Semaglutide API

    from gram-level R&D samples to kilogram-level commercial batches
  • Tirzepatide API

    Product Tirzepatide API

    from gram-level R&D samples to kilogram-level commercial batches
  • Developmental APIs

    Product Developmental APIs

    Small molecule APIs from gram scale to commercial production.
    CMC Services