Drug Product
Company Overview
About
Lee Pharma Limited is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:India
Founded:1993
Employees:638
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 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
3 sites worldwide
Lee Pharma Limited
Plot No. V, Phase-II, VSEZ, Duvvada, Sabbavaram (M), Visakhapatnam, Andhra Pradesh, 530049
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
LEE PHARMA LIMITED
Sy Nos: 30P, 31P, 32P, 34P & 35P, Plot No. 22A & 22B, APSEZ De-Notified Area, Lalam Koduru (V), Rambili (M), Dist, Anakapalli, Andhra Pradesh, 531011
Site Capabilities
1 capabilityAPI MANUFACTURE
Lee Pharma Limited
Survey No 10/G1, Gaddapotharam Village Jinnaram Mandal, Sangareddy, Telangana, 502319
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
16
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval U7KBCK
FDA · #APR-OV0ECSX8 · 2019-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-QAY5LVYU
Issued: 2020-07-02
Expires: 2025-01-02
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-DCBE5KUX
Issued: 2020-11-01
Expires: 2025-01-01
Health Canada GMP
Health Canada
Cert #: CERT-S98JU30B
Issued: 2020-10-07
Expires: 2025-12-16
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Key facts about Lee Pharma Limited
- Lee Pharma Limited is headquartered in India.
- Lee Pharma Limited was founded in 1993.
- Lee Pharma Limited has 638 employees.
- Lee Pharma Limited has 3 manufacturing sites listed on CDMO Hub, in Visakhapatnam, India, Anakapalli, India and Sangareddy, India.
- Lee Pharma Limited's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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