GMP Case study
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API Client Testimonials
  • The facility is clean and organized well. The team is composed of experienced process chemists, QC and QA. They made my client’s delivery in a timely manner with very good quality. Definitely recommend to those who are searching for US-based early development stage GMP API facility.
    --- Biotech Client

PBUSA GMP Projects Examples
GMP API for Phase I study​

—Total 4 GMP steps, SM staged in PharmaBlock Nanjing, 2 GMP steps each in China and US to meet tight timeline.​
—GMP production in China ongoing, GMP production in US target to complete by end of Sep 2023.​
—3-year ICH stability study (40°C/75% RH for 6 months and 25°C/60% RH for 36 months) from Oct. ​

GMP Intermediate/RSM​

—Optimized 4 steps synthesis, scaled up first 3 non-GMP steps in PB China, final step GMP synthesis in US (2 kg)​.
—Analytical method development, validation and COA release.



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