Drug Product
Company Overview
About
Capsulit S.P.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Italy
Founded:2013
Employees:542
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
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval 98L42Z
FDA · #APR-7RGMZ10N · 2018-08-01
Drug Approval 1B2EMY
FDA · #APR-XG39TKD1 · 2020-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-8L2JN86O
Issued: 2020-03-20
Expires: 2025-08-17
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-D3SDUHEQ
Issued: 2020-03-07
Expires: 2025-01-22
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-QDAM5155
Issued: 2020-11-11
Expires: 2025-07-05
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Key facts about Capsulit S.P.A.
- Capsulit S.P.A. is headquartered in Italy.
- Capsulit S.P.A. was founded in 2013.
- Capsulit S.P.A. has 542 employees.
- Capsulit S.P.A.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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