Drug Product
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Company Overview
About
Biomay AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Austria
Founded:2018
Employees:804
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
International Regulatory
EU GMP Certificates
14
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval BJZOMF
Health Canada · #APR-RAHF6OJP · 2022-07-01
Drug Approval BDKHD7
PMDA · #APR-N1I0YMZ5 · 2018-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-8DRYCYBD
Issued: 2020-03-20
Expires: 2025-04-20
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-9MKXGRDL
Issued: 2020-07-01
Expires: 2025-03-16
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-3PCIJWWS
Issued: 2020-02-16
Expires: 2025-08-16
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-7IEU3A1H
Issued: 2020-10-22
Expires: 2025-07-09
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Key facts about Biomay AG
- Biomay AG is headquartered in Austria.
- Biomay AG was founded in 2018.
- Biomay AG has 804 employees.
- Biomay AG's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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