DuoPharma (Duopharma Biotech Berhad)
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Drug Product
Company Overview
About
DuoPharma (Duopharma Biotech Berhad) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Neurology
Quick Facts
HQ:Malaysia
Founded:2003
Employees:1,164
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval S0AA4J
EMA · #APR-GOTMFLXD · 2019-07-01
Drug Approval XHECWT
PMDA · #APR-DGWQTADX · 2018-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-TYQ2QTQN
Issued: 2020-01-25
Expires: 2025-05-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-OEONR7E6
Issued: 2020-01-20
Expires: 2025-02-02
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Key facts about DuoPharma (Duopharma Biotech Berhad)
- DuoPharma (Duopharma Biotech Berhad) is headquartered in Malaysia.
- DuoPharma (Duopharma Biotech Berhad) was founded in 2003.
- DuoPharma (Duopharma Biotech Berhad) has 1,164 employees.
- DuoPharma (Duopharma Biotech Berhad)'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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