Smilax Laboratories Limited
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Drug Product
Company Overview
About
Smilax Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:India
Founded:2017
Employees:2,004
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
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Europe
Manufacturing Facilities
2 sites worldwide
Smilax Laboratories Limited
Plot No.12/A, Phase III, IDA, Jeedimetla, Hyderabad, Telangana, 500055
Site Capabilities
1 capabilityAPI MANUFACTURE
Smilax Laboratories Limited
Plot No :70, Jawaharlal Nehru Pharma City, E-Bonangi Village, Parawada (M), Visakhapatnam, Andhra Pradesh, 531019
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval DJ6UP3
EMA · #APR-9ZOASRF1 · 2021-02-01
Drug Approval 15G98G
PMDA · #APR-BYC4EBW6 · 2022-09-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-YRNX4HDJ
Issued: 2020-06-21
Expires: 2025-10-27
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-QWEPGKMM
Issued: 2020-02-04
Expires: 2025-11-11
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Key facts about Smilax Laboratories Limited
- Smilax Laboratories Limited is headquartered in India.
- Smilax Laboratories Limited was founded in 2017.
- Smilax Laboratories Limited has 2,004 employees.
- Smilax Laboratories Limited has 2 manufacturing sites listed on CDMO Hub, in Hyderabad, India and Visakhapatnam, India.
- Smilax Laboratories Limited's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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