Milan Laboratories (India) Pvt. Ltd.
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Milan Laboratories (India) Pvt. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:India
Founded:1996
Employees:1,802
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Global
Manufacturing Facilities
2 sites worldwide
Milan Laboratories (India) Pvt. Ltd
Plot No. Z-96/A, Dahej SEZ Phase II, Dahej, Gujarat, 392130
Site Capabilities
1 capabilityMANUFACTURE
Milan Laboratories (India) Pvt Ltd
64 65 67 35 36 87 Plot 63, Kamothe Navi Mumbai Road; J C I E Ltd, Panvel
International Regulatory
EU GMP Certificates
5
WHO Prequalified Products
1
Regulatory Bodies
EMA/EudraGMDP
WHO
Regulatory Approvals
Drug Approval 61G97Y
FDA · #APR-6LLVQFZY · 2020-04-01
Drug Approval 9RFK47
FDA · #APR-Y4VBLS79 · 2021-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-FUM19GZF
Issued: 2020-10-04
Expires: 2025-01-20
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-5LEQA73X
Issued: 2020-09-01
Expires: 2025-03-13
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-Y27J0FYA
Issued: 2020-06-15
Expires: 2025-02-14
Health Canada GMP
Health Canada
Cert #: CERT-Y0Y1BSQC
Issued: 2020-12-03
Expires: 2025-12-13
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Key facts about Milan Laboratories (India) Pvt. Ltd.
- Milan Laboratories (India) Pvt. Ltd. is headquartered in India.
- Milan Laboratories (India) Pvt. Ltd. was founded in 1996.
- Milan Laboratories (India) Pvt. Ltd. has 1,802 employees.
- Milan Laboratories (India) Pvt. Ltd. has 2 manufacturing sites listed on CDMO Hub, in Dahej, India and Panvel, India.
- Milan Laboratories (India) Pvt. Ltd.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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