ALPS Pharmaceutical Ind. Co. Ltd.
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Drug Product
Excipients & Specialty Ingredients
Company Overview
About
ALPS Pharmaceutical Ind. Co. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Japan
Founded:2005
Employees:1,886
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Alps Pharmaceutical Ind. Co., Ltd.
8, FURUKAWACHOKAMINO, Hida-shi, Gifu, 509-4263
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
9
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval RIER5L
EMA · #APR-CY260FEJ · 2020-03-01
Drug Approval NEZSCC
Health Canada · #APR-9C09YT70 · 2019-07-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-4V0NMQKM
Issued: 2020-01-05
Expires: 2025-01-10
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-F69R2VBX
Issued: 2020-09-17
Expires: 2025-01-02
Health Canada GMP
Health Canada
Cert #: CERT-AY2QWUNR
Issued: 2020-12-13
Expires: 2025-06-20
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Key facts about ALPS Pharmaceutical Ind. Co. Ltd.
- ALPS Pharmaceutical Ind. Co. Ltd. is headquartered in Japan.
- ALPS Pharmaceutical Ind. Co. Ltd. was founded in 2005.
- ALPS Pharmaceutical Ind. Co. Ltd. has 1,886 employees.
- ALPS Pharmaceutical Ind. Co. Ltd. has one manufacturing site listed on CDMO Hub, in Hida-shi, Japan.
- ALPS Pharmaceutical Ind. Co. Ltd.'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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