Spectrasynth Pharmachem
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Drug Product
Company Overview
About
Spectrasynth Pharmachem is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:India
Founded:1990
Employees:1,284
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Regulatory Approvals
Drug Approval Q6H92V
PMDA · #APR-W42F1TG8 · 2020-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-E589G21X
Issued: 2020-11-18
Expires: 2025-06-07
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-YHSG7FNC
Issued: 2020-08-07
Expires: 2025-03-11
WHO GMP
World Health Organization
Cert #: CERT-1MY9LYZR
Issued: 2020-11-11
Expires: 2025-01-24
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-JMRPVSII
Issued: 2020-04-12
Expires: 2025-04-03
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Key facts about Spectrasynth Pharmachem
- Spectrasynth Pharmachem is headquartered in India.
- Spectrasynth Pharmachem was founded in 1990.
- Spectrasynth Pharmachem has 1,284 employees.
- Spectrasynth Pharmachem's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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