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Global Network & Advanced Production Capabilities

State-of-the-Art Manufacturing & Facilities

14

Manufacturing Facilities

11 in India, plus UK & Mexico plants

2

API & Intermediate Units

Compliant with US FDA & international standards

1B+

Solid Orals / Month

Automated high-speed production capacity

5M+

Injectable Units / Month

Aseptic sterile fill-finish capabilities

Global Manufacturing Scale & Capabilities

Azalium operates fourteen manufacturing facilities, of which eleven are located in India and the rest in the UK and Mexico. The company also has an advanced analytical lab and state-of-the-art distribution centre in the UK. It operates two API and intermediate manufacturing facilities, each of which complies with the regulatory requirements in the jurisdictions in which it operates. Between them, these facilities have received approval from various prominent international regulatory bodies, including from the U.S. Food and Drug Administration (FDA).

Each of Azalium’s manufacturing facilities is designed, equipped and operated to deliver high-quality products within defined cost and delivery schedules. These manufacturing facilities have the flexibility to operate in various dosage forms and a wide range of batch sizes. Azalium’s world class oncology formulation facility operates under global regulatory and safety standards. The SEZ manufacturing units cater exclusively to the US, Europe and other regulated markets.

As a part of its progressive future strategy, Azalium has invested in Pharmez 2 – a highly advanced expansion of its Pharmez SEZ facility in Gujarat, India. This new age, highly automated and efficient manufacturing layout has the capacity to produce more than one billion solid orals per month as well as 5 million injectable units. The futuristic Pharmez 2 facility is set to be the cornerstone for Azalium’s promising future.

Our Production Sites

State-of-the-Art Manufacturing Plants

Azalium Pharmaceutical Private Limited operates world-class manufacturing units that synthesize active ingredients and package finished formulations. Each site leverages automation and strict process engineering to guarantee compliance and safety.

Pharmez 2 SEZ Facility - Gujarat, India

High-Volume Solid Orals & Injectables

A futuristic, highly automated expansion featuring high-speed production lines with capacity for over 1 billion solid orals and 5 million injectable units monthly.

Key Regulatory Approvals & Standards:
US FDA EU GMP WHO GMP ANVISA

Formulations Facility Unit I - SEZ Hub

Oral Solid Dosage & Liquid Formulations

Dedicated formulation facility producing high-quality tablets, capsules, and oral suspensions for regulated US and European markets.

Key Regulatory Approvals & Standards:
US FDA EU GMP UK MHRA WHO GMP

Sterile Injectables Unit II - Biotech Park

Liquid & Lyophilized Vials, Pre-filled Syringes

Advanced sterile fill-finish plant operating under ISO 5 aseptic standards with state-of-the-art Restricted Access Barrier Systems (RABS).

Key Regulatory Approvals & Standards:
US FDA EMA MHRA PMDA Japan

API & Intermediate Unit III - Industrial Complex

Chemical Synthesis & Bulk Drug Substances

Specialized API facility catering to complex synthesis and supplying high-purity active pharmaceutical ingredients globally.

Key Regulatory Approvals & Standards:
US FDA EDQM KFDA Korea WHO GMP

Analytical Lab & Distribution Centre - United Kingdom

Quality Control, Testing & Global Logistics

State-of-the-art analytical testing laboratory and strategic distribution node serving the UK and European pharmaceutical supply chain.

Key Regulatory Approvals & Standards:
UK MHRA EU GMP

Oncology & Biologics Unit IV - High-Potency Hub

Cytotoxic Formulations & Biosimilars

World-class high-containment oncology formulation facility operating under stringent global containment and safety protocols.

Key Regulatory Approvals & Standards:
US FDA EU GMP WHO GMP
Quality Commitment

Uncompromising Quality at Every Step of the Value Chain

Every product under the Azalium Pharmaceutical Pvt Ltd brand undergoes rigorous physicochemical, microbial, and stability testing. We maintain end-to-end quality control—from active pharmaceutical ingredient (API) sourcing to secondary packaging—ensuring batch-to-batch consistency, bioequivalence, and therapeutic efficacy.

Regulatory Standards

Regulatory Standards

All formulations adhere to stringent WHO-cGMP, ISO, and revised Schedule M manufacturing standards.

Raw Material Integrity

Raw Material Integrity

Premium Active Pharmaceutical Ingredients (APIs) and excipients sourced exclusively from audited, certified manufacturers.

Analytical Testing

Analytical Testing

Comprehensive physicochemical, microbial, and instrumental analysis (HPLC, dissolution, stability testing) for every batch.

Packaging Integrity

Packaging Integrity

High-barrier packaging engineered to maintain maximum drug efficacy and stability across global climatic zones.

Looking for Custom Manufacturing or Global Supply Partnerships?

Partner with Azalium for reliable, high-capacity, cGMP-compliant pharmaceutical manufacturing and supply chain solutions.