Softgel Healthcare Pvt Ltd
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Drug Product
Company Overview
About
Softgel Healthcare Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:India
Founded:2012
Employees:1,198
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 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Manufacturing Facilities
2 sites worldwide
SOFTGEL HEALTHCARE PRIVATE LIMITED
Plot Nos. 9, 10 & 44, Onehub, Kunnapattu, Chengalpattu, Tamilnadu, 603105
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
SOFTGEL HEALTHCARE PRIVATE LIMITED
Survey No. 20/1, Vandalur Kelambakkam Road, Pudupakkam, Chengalpattu, Tamilnadu, 603103
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 9AXTO8
EMA · #APR-J3RL2R5U · 2021-12-01
Drug Approval JI2R0M
EMA · #APR-P1NY1FQR · 2021-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ER8RXU3D
Issued: 2020-07-16
Expires: 2025-07-15
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-2RLLUIZG
Issued: 2020-09-16
Expires: 2025-05-17
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Key facts about Softgel Healthcare Pvt Ltd
- Softgel Healthcare Pvt Ltd is headquartered in India.
- Softgel Healthcare Pvt Ltd was founded in 2012.
- Softgel Healthcare Pvt Ltd has 1,198 employees.
- Softgel Healthcare Pvt Ltd has 2 manufacturing sites listed on CDMO Hub, in Chengalpattu, India.
- Softgel Healthcare Pvt Ltd's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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