CCSB (Chunghwa Chemical Synthesis & Biotech)

Taiwan

Profile last updated: 2026-10-28

Hybrid — also manufactures internal programs

Small Molecule API

Program data pending ClinicalTrials.gov matching

Profiled

Not yet scored

✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (4)

Quick Facts: CCSB (Chunghwa Chemical Synthesis & Biotech)

Signal Score: Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters: Taiwan
Website: https://www.ccsb.com.tw/
Modalities: Small Molecule API
Active Programs: No ClinicalTrials.gov matches confirmed
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About CCSB (Chunghwa Chemical Synthesis & Biotech)

CCSB (Chunghwa Chemical Synthesis & Biotech) makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.ccsb.com.tw/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

CCSB (Chunghwa Chemical Synthesis & Biotech) FDA Inspection History

2024-04

2022-11

NAI VAI OAI

Date	Site	Type	Observations	Classification
2024-04-12	Chunghwa Chemical Synthesis & Biotech Co., Ltd New Taipei City Company-level	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)
2022-11-18	Chunghwa Chemical Synthesis & Biotech Co., Ltd New Taipei City Company-level	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)

Source: FDA Data Dashboard · Retrieved Nov 01, 2026

Japan-accredited overseas site (PMDA)

general (non-sterile) · 1 site

New Taipei, Taiwan · Chunghwa Chemical Synthesis & Biotech Co., Ltd. — general (non-sterile) · valid to Jul 29, 2027

Previously accredited (cancelled) · 1

New Taipei, Taiwan · Chunghwa Chemical Synthesis & Biotech Co., Ltd. — general (non-sterile) · cancelled Nov 2, 2012

No longer on PMDA's current list. Shown for history only; not used in search tags.

PMDA accreditation of a foreign manufacturing site is recognition within Japan's regulatory system, not an inspection outcome. PMDA's list covers only manufacturing sites outside Japan, so a company's plants in Japan are not on it. Source: PMDA, list of accredited/registered foreign manufacturers (as of Oct 16, 2026), Public Data License 1.0 (terms)

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this

No hiring data. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.

Source: public careers pages · Checked Oct 31, 2026

Frequently Asked Questions About CCSB (Chunghwa Chemical Synthesis & Biotech)

How many FDA inspections does CCSB (Chunghwa Chemical Synthesis & Biotech) have on record?

CDMO Signal tracks 2 FDA inspections for CCSB (Chunghwa Chemical Synthesis & Biotech), sourced from the FDA inspection database. See the full inspection history above.

Has CCSB (Chunghwa Chemical Synthesis & Biotech) received an FDA warning letter?

CDMO Signal has no FDA warning letters on record for CCSB (Chunghwa Chemical Synthesis & Biotech).

Does CCSB (Chunghwa Chemical Synthesis & Biotech) have a CDMO Signal Score?

Not yet. CCSB (Chunghwa Chemical Synthesis & Biotech) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.

Evaluating CCSB (Chunghwa Chemical Synthesis & Biotech) for a manufacturing program?

Use the free AI matchmaker to compare CCSB (Chunghwa Chemical Synthesis & Biotech) against other CDMOs by FDA, EMA, and clinical-trial data — no login required.

Find & compare CDMOs →

Represent this organization? Contact us to verify or update this profile.