Excipients & Specialty Ingredients
Company Overview
About
Bitop AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Germany
Founded:2004
Employees:1,486
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 6J3G0T
EMA · #APR-MZIWDQ6J · 2020-04-01
Drug Approval E55MCY
FDA · #APR-VI7DM7KZ · 2021-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-N42G0TZI
Issued: 2020-02-27
Expires: 2025-01-16
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-BZZYAX8X
Issued: 2020-10-08
Expires: 2025-02-23
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-HL8B4GCD
Issued: 2020-05-25
Expires: 2025-12-26
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Key facts about Bitop AG
- Bitop AG is headquartered in Germany.
- Bitop AG was founded in 2004.
- Bitop AG has 1,486 employees.
- Bitop AG's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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