Elementis Pharma GmbH
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Excipients & Specialty Ingredients
Company Overview
About
Elementis Pharma GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:2010
Employees:862
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
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Elementis Pharma Gmbh
Giulinistr 2, Ludwigshafen Am Rhein, 67065
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval N2W5DG
EMA · #APR-TX72DWMO · 2018-06-01
Drug Approval BX1UPO
FDA · #APR-904GT19G · 2019-08-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-HSUE5WR4
Issued: 2020-11-14
Expires: 2025-08-11
WHO GMP
World Health Organization
Cert #: CERT-DCZ3ZP87
Issued: 2020-12-28
Expires: 2025-07-19
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-NHVON1W8
Issued: 2020-01-01
Expires: 2025-07-25
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Key facts about Elementis Pharma GmbH
- Elementis Pharma GmbH is headquartered in Germany.
- Elementis Pharma GmbH was founded in 2010.
- Elementis Pharma GmbH has 862 employees.
- Elementis Pharma GmbH has one manufacturing site listed on CDMO Hub, in Ludwigshafen Am Rhein, Germany.
- Elementis Pharma GmbH's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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