Drug Product
Company Overview
About
Inke S.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Spain
Founded:2018
Employees:2,852
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
INKE SA
Calle Argent (AREA INDUSTRIAL DEL LLOBREGAT) 1, Castellbisbal, 08755
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 0ATPMA
Health Canada · #APR-EXR26YB2 · 2021-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-KUR5MWNT
Issued: 2020-10-20
Expires: 2025-11-15
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-FXF3IL7C
Issued: 2020-10-10
Expires: 2025-02-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-049XA1BM
Issued: 2020-06-09
Expires: 2025-01-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-FN5UU1PL
Issued: 2020-04-04
Expires: 2025-04-20
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Key facts about Inke S.A.
- Inke S.A. is headquartered in Spain.
- Inke S.A. was founded in 2018.
- Inke S.A. has 2,852 employees.
- Inke S.A. has one manufacturing site listed on CDMO Hub, in Castellbisbal, Spain.
- Inke S.A.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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