Excipients & Specialty Ingredients
Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
ELKALUB Lubricants is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:2014
Employees:491
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
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval UKN70J
Health Canada · #APR-V39HMR5O · 2018-06-01
Drug Approval DCL8B2
EMA · #APR-NHM6KMCC · 2018-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-AS7PFJAS
Issued: 2020-09-02
Expires: 2025-11-20
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-BKD6M654
Issued: 2020-03-04
Expires: 2025-01-06
Health Canada GMP
Health Canada
Cert #: CERT-SE32DDCJ
Issued: 2020-09-26
Expires: 2025-10-28
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-1WOL6IBU
Issued: 2020-01-08
Expires: 2025-07-23
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Key facts about ELKALUB Lubricants
- ELKALUB Lubricants is headquartered in Germany.
- ELKALUB Lubricants was founded in 2014.
- ELKALUB Lubricants has 491 employees.
- ELKALUB Lubricants's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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