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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 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 Americas 2025

Pennsylvania Convention Center, Philadelphia
20 May 2025 - 22 May 2025
View Exhibitor Profile

Products from Chemspec- API (5)