Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Metrochem API 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:2003
Employees:3,072
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
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
4 sites worldwide
Metrochem API Private Limited
Unit-I, Plot No. 62/C/6, Phase 1, Pipeline Road, Hyderabad
Metrochem API Private Limited
Unit - IV, Plot No. 34B, 40B & 60B, J.N. Pharma City, Thanam Village, Parawada Mandal, Anakapalli District, Andhra Pradesh, 531021
Site Capabilities
1 capabilityAPI MANUFACTURE
METROCHEM API PRIVATE LIMITED
Unit-C, Plot No 3 & 4, Survey No 42, Alinagar Jinnaram Mandal, Chetlapotharam Revenue Village, Sangareddy, Telangana, 502319
Site Capabilities
1 capabilityAPI MANUFACTURE
Metrochem API Private Limited
Unit-B, Sy No. 530 & 534, Temple Road, Bonthapally Village, Gummadidala Mandal,, Sangareddy, Telangana, 502313
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval L0IN06
EMA · #APR-6LPYVE1O · 2019-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ABL91P8T
Issued: 2020-06-19
Expires: 2025-12-13
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-4BAZ44RL
Issued: 2020-12-27
Expires: 2025-03-20
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-ZG20T1MA
Issued: 2020-02-07
Expires: 2025-09-18
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Key facts about Metrochem API Pvt Ltd
- Metrochem API Pvt Ltd is headquartered in India.
- Metrochem API Pvt Ltd was founded in 2003.
- Metrochem API Pvt Ltd has 3,072 employees.
- Metrochem API Pvt Ltd has 4 manufacturing sites listed on CDMO Hub, in Hyderabad, India, Anakapalli District, India and Sangareddy, India.
- Metrochem API Pvt Ltd's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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