Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Kincell Bio is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:1993
Employees:2,462
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 4 (1-10 µg/m³)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval 7KV8TD
EMA · #APR-PERABLGC · 2022-08-01
Drug Approval IKNUBC
EMA · #APR-1RC9XUFA · 2022-11-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-Y92IKSAP
Issued: 2020-11-09
Expires: 2025-01-07
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-Z246BF7N
Issued: 2020-06-27
Expires: 2025-07-15
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-AJN49PVA
Issued: 2020-07-17
Expires: 2025-09-11
Loading CDMO intelligence...
Key facts about Kincell Bio
- Kincell Bio is headquartered in the United States.
- Kincell Bio was founded in 1993.
- Kincell Bio has 2,462 employees.
- Kincell Bio's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
Find CDMOs like Kincell Bio
Directory pages this company appears in, each with the full list of matching manufacturers.