Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Milsing d.o.o. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Croatia
Founded:2010
Employees:2,597
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval WTMXRX
FDA · #APR-6NIFP26J · 2022-10-01
Drug Approval EJY8II
PMDA · #APR-N26LRXEW · 2020-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-I7YEDORZ
Issued: 2020-03-21
Expires: 2025-10-16
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-XG2RLXSJ
Issued: 2020-06-03
Expires: 2025-03-16
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Key facts about Milsing d.o.o.
- Milsing d.o.o. is headquartered in Croatia.
- Milsing d.o.o. was founded in 2010.
- Milsing d.o.o. has 2,597 employees.
- Milsing d.o.o.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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