EmergoPharm Sp. z o.o. Sp. K.
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Drug Product
Company Overview
About
EmergoPharm Sp. z o.o. Sp. K. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:Poland
Founded:2004
Employees:1,878
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval 7EYT9Q
PMDA · #APR-ZSVM8NSX · 2021-09-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-YR09TR6M
Issued: 2020-04-19
Expires: 2025-09-21
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-6H9D7OIU
Issued: 2020-07-25
Expires: 2025-07-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-XCNYX1I6
Issued: 2020-05-23
Expires: 2025-03-05
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-SBUDXJLY
Issued: 2020-06-28
Expires: 2025-02-12
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Key facts about EmergoPharm Sp. z o.o. Sp. K.
- EmergoPharm Sp. z o.o. Sp. K. is headquartered in Poland.
- EmergoPharm Sp. z o.o. Sp. K. was founded in 2004.
- EmergoPharm Sp. z o.o. Sp. K. has 1,878 employees.
- EmergoPharm Sp. z o.o. Sp. K.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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