Drug Product
Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
KareBay Biochem is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:China
Founded:2003
Employees:2,277
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 0QQE1L
EMA · #APR-VU85ZK1Y · 2021-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-UTAHGZK8
Issued: 2020-12-26
Expires: 2025-06-25
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GJ254NG1
Issued: 2020-02-02
Expires: 2025-02-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-VVXS0N5O
Issued: 2020-01-03
Expires: 2025-12-09
WHO GMP
World Health Organization
Cert #: CERT-X7G3NNMD
Issued: 2020-08-13
Expires: 2025-11-06
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Key facts about KareBay Biochem
- KareBay Biochem is headquartered in China.
- KareBay Biochem was founded in 2003.
- KareBay Biochem has 2,277 employees.
- KareBay Biochem's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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