CN

Shanghai Fengxian Manufacturing Site

The Porton Shanghai Fengxian Manufacturing Site is an advanced, high-standard GMP manufacturing facility specializing in the production of API for small molecules and Tides drugs.
No.99, Lianhe North Road, Fengxian District, Shanghai, China

    64,480m2Total Factory

    The site is equipped with a variety of reactors of different specifications, ranging in size from 10 liters to 6,300 liters.

    75.5m3Total Capacity

    We can ensure the capability to meet production demands of up to hundreds of kilograms.

    2NewAPIs Approved

    We can provide new drug manufacturing services from IND to NDA.

Services

cGMP - Small Molecule cGMP - Tides/HPs
cGMP - Small Molecule
Porton offers efficient, flexible, and high-quality solutions for custom development and production of small molecule APIs, as well as technical services throughout the entire lifecycle from pre-clinical to commercial stages to our worldwide partners.
  • PCC, GLP Tox, GMP
  • IND, PV, NDA
  • Up to 100+ Kg Scale API"

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cGMP - Tides/HPs
With five major R&D platforms, including peptides, oligonucleotides, conjugated drugs, high-performance liquid chromatography, and Tides analysis, the Porton Tides CDMO Services Platform is committed to providing integrated CMC solutions for global customers, covering all types of new drugs from pre-clinical to commercial.
  • Polypeptide, Oligonucleotide, Payload-Linker
  • High Potent Compound Handling
  • Lyophilization, RPC, etc.

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One Porton One Quality

Compliance standards, Continuous improvement, Customer oriented

Quality management runs throughout the entire process of the drug life cycle. The quality management system of the drug product site is built in accordance with international standards and continues to adhere to the quality concept of 'more well-established system, more controllable quality.' This ensures that the GMP activities of the drug product site meet the requirements of international quality management systems and market drug regulatory agencies, including those of China, the European Union, FDA, and other mainstream regulations.

  • Inspections from NPMA (2 API) in 2023
  • 14+ Quality Audit from Clients in 2023
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