Chemspec-API

About Chemspec-API

Chemspec-API is an FDA inspected small molecule CMO. Our New Jersey R&D and GMP manufacturing facility is supplemented 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 and GMP intermediates at Shanghai Chemspec

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Certifications
  • FDA
    FDA
  • GMP
    GMP
  • Other
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Sales Markets
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Categories
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  • US
  • 2023
    On CPHI since
  • 3
    Certificates
  • 1 - 24
    Employees
Company types
CMO/CDMO
Primary activities
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Generic APIs producer
Regulatory Affairs
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Contact info
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Meet us at

CPHI North America 2024

Pennsylvania Convention Center, Philadelphia
07 May 2024 - 09 May 2024
View Exhibitor Profile

CPHI Milan 2024

Fiera Milano, Italy
08 Oct 2024 - 10 Oct 2024
View Exhibitor Profile

Products from Chemspec-API (2)

  • Developmental APIs

    Product Developmental APIs

    Small molecule APIs from gram scale to commercial production.
    CMC Services
  • Generic API Product List

    Product Generic API Product List

    Menadiol sodium diphosphate, USP. [6700-42-1]
    Isocarboxazid, USP. [59-63-2]
    Procarbazine HCl, USP. [366-70-1]
    Calcium Levomefolate, USP. [151533-22-1]
    CMC support (ANDA/DMF, MA/ASMF)