Kunststoffwerk Kremsmünster GmbH
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Manufacturing & Lab Equipment
Company Overview
About
Kunststoffwerk Kremsmünster GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Austria
Founded:1990
Employees:880
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
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
Regulatory Approvals
Drug Approval Q6PFLS
PMDA · #APR-FKO4MM5J · 2021-04-01
Drug Approval 2DAWNT
FDA · #APR-ZZC70E04 · 2019-09-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-RUUNB48H
Issued: 2020-12-03
Expires: 2025-04-26
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-O7WJ755W
Issued: 2020-04-28
Expires: 2025-04-17
WHO GMP
World Health Organization
Cert #: CERT-0485A4CH
Issued: 2020-09-13
Expires: 2025-10-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-9M38E0RC
Issued: 2020-09-12
Expires: 2025-10-12
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Key facts about Kunststoffwerk Kremsmünster GmbH
- Kunststoffwerk Kremsmünster GmbH is headquartered in Austria.
- Kunststoffwerk Kremsmünster GmbH was founded in 1990.
- Kunststoffwerk Kremsmünster GmbH has 880 employees.
- Kunststoffwerk Kremsmünster GmbH's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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