Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
CellMark AB is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Sweden
Founded:1990
Employees:1,780
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Keshava Organics Private Limited
T-97, 98, 99 & 100, MIDCTarapur Boisar, Palghar, MH, 401506
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval S5PKDT
FDA · #APR-KNCIMFNT · 2020-02-01
Drug Approval 130840
EMA · #APR-F0TJY6AB · 2018-08-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-NXITPKX3
Issued: 2020-02-20
Expires: 2025-09-17
WHO GMP
World Health Organization
Cert #: CERT-GTOSNW27
Issued: 2020-09-25
Expires: 2025-01-20
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-2V9A2VR6
Issued: 2020-09-10
Expires: 2025-03-25
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Key facts about CellMark AB
- CellMark AB is headquartered in Sweden.
- CellMark AB was founded in 1990.
- CellMark AB has 1,780 employees.
- CellMark AB has one manufacturing site listed on CDMO Hub, in Palghar, India.
- CellMark AB's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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