Symbiotica Speciality Ingredients Sdn Bhd
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Symbiotica Speciality Ingredients Sdn Bhd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Malaysia
Founded:1991
Employees:2,491
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Symbiotica Speciality Ingredients Sdn. Bhd.
No. 518, Jalan Waja 4, Taman Industri Waja, Kulim, Kedah, 09000
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval L2AORD
FDA · #APR-76MVE8DV · 2021-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-AOREKEYS
Issued: 2020-08-16
Expires: 2025-11-11
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-1FXLNCQK
Issued: 2020-01-08
Expires: 2025-10-13
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-6LDKYLYQ
Issued: 2020-08-01
Expires: 2025-10-27
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-G2WN3JQZ
Issued: 2020-10-18
Expires: 2025-06-26
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Key facts about Symbiotica Speciality Ingredients Sdn Bhd
- Symbiotica Speciality Ingredients Sdn Bhd is headquartered in Malaysia.
- Symbiotica Speciality Ingredients Sdn Bhd was founded in 1991.
- Symbiotica Speciality Ingredients Sdn Bhd has 2,491 employees.
- Symbiotica Speciality Ingredients Sdn Bhd has one manufacturing site listed on CDMO Hub, in Kulim, Malaysia.
- Symbiotica Speciality Ingredients Sdn Bhd's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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