Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Syngene International is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:India
Founded:2010
Employees:1,789
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 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
4 sites worldwide
Syngene International Limited
MSEZ, Plot No. IP-39, IP-46 & IP-60, IP-25 (Part) & IP-61 (Part) Kalavar Village & Post, Dakshina Kannada, Mangaluru, Karnataka, 574142
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
Syngene International Limited
Plot No. 31, Clinical Development, Tower 1, Semicon Park, Bengaluru, Karnataka, 560100
Site Capabilities
1 capabilityANALYSIS
SYNGENE INTERNATIONAL LIMITED
Unit 3, No: 68/A, Bommasandra Industrial Area, I Phase, Hosur Road, Anekal, Bengaluru, Karnataka, 560099
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
SYNGENE INTERNATIONAL LIMITED
Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka, 560099
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval ES5KRC
EMA · #APR-VLSZ5BPW · 2022-11-01
Drug Approval SGDQKV
PMDA · #APR-WWZO300X · 2020-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-MKTAXLYA
Issued: 2020-02-03
Expires: 2025-10-26
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-O3OL8CB8
Issued: 2020-05-18
Expires: 2025-09-02
Loading CDMO intelligence...
Key facts about Syngene International
- Syngene International is headquartered in India.
- Syngene International was founded in 2010.
- Syngene International has 1,789 employees.
- Syngene International has 4 manufacturing sites listed on CDMO Hub, in Mangaluru, India and Bengaluru, India.
- Syngene International's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
Find CDMOs like Syngene International
Directory pages this company appears in, each with the full list of matching manufacturers.