Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
BIOSTILE d.o.o. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Slovenia
Founded:2016
Employees:1,043
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
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval 2QVJ3P
FDA · #APR-8Y8KMMK1 · 2018-08-01
Drug Approval 30NT00
FDA · #APR-1SAX75NC · 2022-10-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-4KZT84JD
Issued: 2020-10-19
Expires: 2025-12-24
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-E993JBBA
Issued: 2020-12-21
Expires: 2025-01-21
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-DCDP83D1
Issued: 2020-05-21
Expires: 2025-05-02
Health Canada GMP
Health Canada
Cert #: CERT-MV5YE2NL
Issued: 2020-09-02
Expires: 2025-03-10
Loading CDMO intelligence...
Key facts about BIOSTILE d.o.o.
- BIOSTILE d.o.o. is headquartered in Slovenia.
- BIOSTILE d.o.o. was founded in 2016.
- BIOSTILE d.o.o. has 1,043 employees.
- BIOSTILE d.o.o.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
Find CDMOs like BIOSTILE d.o.o.
Directory pages this company appears in, each with the full list of matching manufacturers.