Gland Pharma Limited

Overview

Gland Pharma Limited is a contract development and manufacturing organization (CDMO) specializing in sterile injectable pharmaceuticals and active pharmaceutical ingredients (APIs). The company operates a vertically integrated manufacturing and R&D platform with facilities across India.

Manufacturing Capabilities

Formulation Manufacturing

Gland Pharma operates four best-in-class, cGMP-compliant formulation manufacturing facilities that produce a wide range of injectables using aseptic filling or terminal sterilization:

• Dundigal, Hyderabad (600,000 sq. ft. flagship facility, USFDA approved since 2003):
• 6 vial lines with 7 lyophilizers: 240 million units/year & 48 million lyophilized units/year
• 1 ampoule line: 60 million units/year
• 2 prefilled syringe (PFS) lines: 60 million units/year
• 2 bag filling lines: 5 million units/year
• 1 ophthalmic line: 45 million units/year

• Pashamylaram, Hyderabad (USFDA approved April 2016):
• 2 vial lines for liquid filling: 132 million units/year
• 1 vial line with 3 lyophilizers: 18 million units/year
• 2 ampoule lines: 120 million units/year

• Penems, Hyderabad (USFDA approved April 2016):
• Dry powder line: 4 million units/year
• Liquid vial line with two lyophilizers: 8 million lyophilized units/year

• Oncology Facility, SEZ Visakhapatnam (USFDA and GMP EU approved 2014):
• 3 vial lines with 4 lyophilizers: 11 million units/year & 5 million lyophilized units/year

API Manufacturing

Gland Pharma operates four API facilities with in-house manufacturing capabilities:

• 2 API facilities at Visakhapatnam with cumulative capacity of 11,000 kg/year
• 1 R&D Pilot Plant at Dundigal, Hyderabad for development and lab-scale manufacturing
• 1 Biotech Drug Substance Facility at Genome Valley, Hyderabad

The company's vertical integration strategy provides better control of supply chain and cost efficiencies, particularly for critical APIs.

Research & Development

Two state-of-the-art R&D divisions in Hyderabad staffed by nearly 300 qualified scientists engage in:

• Formulation Development
• Analytical Method Development
• API Process Development
• Stability Studies
• Synthesis of complex drug molecules including LMWH, corticosteroids, peptides, and cytotoxic molecules
• Synthetic R&D process development for niche APIs
• Patent non-infringing process development
• Pilot and scale-up studies
• Pre-formulation studies
• Lyophilization cycle development and scale-up
• Analytical method development and validation
• Impurity determination and characterization

Regulatory Approvals

All facilities are USFDA approved. Additional global approvals include:

• MHRA (United Kingdom)
• EMA (European Union)
• TGA (Australia)
• ANVISA (Brazil)
• BGV Hamburg (Germany)
• WHO (World Health Organization)
• Health Canada
• MCC (South Africa)

Operational Strengths

The company emphasizes production flexibility across its formulation facilities, enabling seamless switching between product lines to meet market demand without requiring additional production line installations.