Stelis Biopharma

CDMO

India

https://www.stelis.com/

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Advanced Modalities

Drug Product

Analytical & Bioanalytical Services

Chemistry, Manufacturing and Controls

Company Overview

About

Stelis Biopharma 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:2019

Employees:1,022

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

Commercial Scale

Large Scale (Metric Ton+)

Markets Served

North America

Europe

International Regulatory

EU GMP Certificates

Regulatory Bodies

EMA/EudraGMDP

Regulatory Approvals

Drug Approval Y058XJ

FDA · #APR-TOLE8S9R · 2022-05-01

Certifications

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-CJON1U86

Issued: 2020-12-06

Expires: 2025-05-05

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-K6QCFBDW

Issued: 2020-04-06

Expires: 2025-02-22

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-012R9UIS

Issued: 2020-03-19

Expires: 2025-10-18

Health Canada GMP

Health Canada

Cert #: CERT-I3X11DKJ

Issued: 2020-09-02

Expires: 2025-12-28

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Key facts about Stelis Biopharma

Stelis Biopharma is headquartered in India.
Stelis Biopharma was founded in 2019.
Stelis Biopharma has 1,022 employees.
Stelis Biopharma's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

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