Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
AnaSpec, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:United States
Founded:2007
Employees:2,014
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
BSL-2 (Biosafety Level 2)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
AnaSpec Inc.
34801 Campus Drive, Fremont, California, 94555
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval 5JOH2G
EMA · #APR-OWO79O4L · 2021-01-01
Drug Approval REG5YF
FDA · #APR-WGKW6FFK · 2020-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-QX65569A
Issued: 2020-11-18
Expires: 2025-08-22
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-JZQ88XZQ
Issued: 2020-10-14
Expires: 2025-08-02
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-SXUV2M8H
Issued: 2020-02-21
Expires: 2025-04-08
Health Canada GMP
Health Canada
Cert #: CERT-LWIFVCTZ
Issued: 2020-04-07
Expires: 2025-08-26
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Key facts about AnaSpec, Inc.
- AnaSpec, Inc. is headquartered in the United States.
- AnaSpec, Inc. was founded in 2007.
- AnaSpec, Inc. has 2,014 employees.
- AnaSpec, Inc. has one manufacturing site listed on CDMO Hub, in Fremont, United States.
- AnaSpec, Inc.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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