About Us

Guangdong Fitakh Pharmaceutical Biotechnology Co., Ltd.

50~100
Employees
2020
Year Established
Manufacturer, Trading Company
Business Type

Company Brief Introduction

FITAKH was established in 2020, headquatered in Huadu district, Guangzhou City. We're professional manufacturer focusing on R&D and production of biodegradable and high-end regenerative microspheres (including PLLA, PDLLA,CaHA, PCL) and cosmetic peptide raw materials. 

Holds valid Class II Medical Device Production License issued by China NMPA, passes ISO13485 international quality system certification and GMP compliance audit. Supported by our in-house professoinal R&D laboratory and senior registration compliance expert team. FITAH has always adhered to innovative research on raw‑material technologies, continuously developing high‑quality and compliant regenerative biomaterials. Going forward, we will join hands with global partners to explore the vast market of regenerative medical aesthetic, and drive the standardized and high‑quality development of the aesthetic‑medical raw‑material industry.

Core Advantages·Why Choose Us

♦ Solid Qualifications

   Master File(MDMF) Registration completed for full‑range raw materials(PCL / PLLA / CaHA / PDRN / Silk fibroin / Recombinant collagen)

♦ University‑Enterprise Collaborative Technical Team

   UCTC(University of Science and Technology of China) Biomedical PhD Team

♦ Full‑range Testing with Traceable Data

  ·Particle size detection(SEM+laser)

  ·Biocompatibility test report

  ·Degradation cycle test(Q/FTF1688S-2025)

  ·Sterility testingµbial limit(CHP/USP dual standard)

♦ Reliable Delivery Capacity

  ·Factory direct supply

  ·Dual system of R&D & mass production

  ·Degradation cycle test(Q/FTF1688S-2025)

  ·Strict internal quality control, consistent batch performance, identical quality between samples and contract goods

China ISO13485 Medical Device Quality Certification
ISO13485 Medical Device Quality Certification
China Class II Medical Device Production License
Class II Medical Device Production License
China Class III Medical Device Business License
Class III Medical Device Business License
China ISO10993 MTT Cytotoxicity Test Report
ISO10993 MTT Cytotoxicity Test Report
China ISO10993 Pyrogen Test Report
ISO10993 Pyrogen Test Report
China ISO10993 MTT Cytotoxicity Test Report
ISO10993 MTT Cytotoxicity Test Report
China ISO10993 Pyrogen Test Report
ISO10993 Pyrogen Test Report
China ISO10993 MTT Cytotoxicity Test Report
ISO10993 MTT Cytotoxicity Test Report
China ISO10993 Pyrogen Test Report
ISO10993 Pyrogen Test Report
China ISO10993 MTT Cytotoxicity Test Report
ISO10993 MTT Cytotoxicity Test Report
China Class III Medical Device Business License
Class III Medical Device Business License