--- name: Gland Pharma Limited slug: gland-pharma site: cdmo website_domain: glandpharma.com summary: Gland Pharma is a vertically integrated CDMO offering sterile injectable manufacturing across vials, lyophilized, prefilled syringes, and ophthalmic formats, with four cGMP-compliant formulation facilities and four API manufacturing units, supported by R&D capabilities in formulation, analytical, and process development. Headquartered in Hyderabad, India. tagline: Vertically integrated CDMO for sterile injectables and APIs with USFDA-approved facilities and global regulatory clearances. founded_year: employee_count_band: 1001-5000 employee_count_label: 1,001–5,000 parent_name: parent_slug: hq_country: IN tier2_domain_verified: false updated_at: 2026-08-08T00:02:04.689Z services_count: 10 modalities_count: 2 indications_count: 0 locations_count: 8 review_signal_gate: closed generated_by: BioBM Editorial AI --- # Gland Pharma Limited Vertically integrated CDMO for sterile injectables and APIs with USFDA-approved facilities and global regulatory clearances. Listed on cdmo.directory. ## Summary Gland Pharma is a vertically integrated CDMO offering sterile injectable manufacturing across vials, lyophilized, prefilled syringes, and ophthalmic formats, with four cGMP-compliant formulation facilities and four API manufacturing units, supported by R&D capabilities in formulation, analytical, and process development. Headquartered in Hyderabad, India. ## At a glance - Employees (est.): 1,001–5,000 - HQ country: IN ## Services - API Synthesis & Manufacturing - Process Development - Formulation Development - CMC Analytical Development - Stability Testing & Storage - Vial Filling - Lyophilization (Freeze Drying) - Prefilled Syringe (PFS) Filling - Ophthalmic Manufacturing - Sterile Fill-Finish & Aseptic Manufacturing ## Modalities - Small Molecule - Biologics (Other) ## Locations - Headquarters / Dundigal Formulation Facility, Hyderabad, Telangana, India - Pashamylaram Formulation Facility, Hyderabad, Telangana, India - Penems Formulation Facility, Hyderabad, Telangana, India - R&D Pilot Plant, Dundigal, Hyderabad, Telangana, India - Biotech Drug Substance Facility, Genome Valley, Hyderabad, Telangana, India - API Manufacturing Facility 1, Visakhapatnam, Andhra Pradesh, India - API Manufacturing Facility 2, Visakhapatnam, Andhra Pradesh, India - Oncology Facility, Visakhapatnam, Andhra Pradesh, India ## Certifications - FDA; Identifier: USFDA; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - MHRA; Identifier: MHRA; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - EMA; Identifier: EMA; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - ANVISA; Identifier: ANVISA; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - TGA; Identifier: TGA; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - BGV Hamburg; Identifier: BGV; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - WHO; Identifier: WHO; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - Health Canada; Identifier: Health Canada; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities - MCC; Identifier: MCC; Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities ## Long description ## 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. ## Related companies - [Ascendiacdmo](/companies/ascendiacdmo) (Process Development, Formulation Development) — [Compare](/compare/ascendiacdmo/gland-pharma) - [Akums Drugs and Pharmaceuticals Ltd.](/companies/akums) (API Synthesis & Manufacturing, Process Development) — [Compare](/compare/akums/gland-pharma) - [Pyramid Pharma Services](/companies/pyramid-pharma-services) (Process Development, Formulation Development) — [Compare](/compare/gland-pharma/pyramid-pharma-services) - [Ascendia Pharmaceutical Solutions](/companies/ascendiapharma) (API Synthesis & Manufacturing, Process Development) — [Compare](/compare/ascendiapharma/gland-pharma) - [Pfizer CentreOne](/companies/pfizercentreone) (Process Development, Formulation Development) — [Compare](/compare/gland-pharma/pfizercentreone) - [Simtra BioPharma Solutions](/companies/simtrabps) (API Synthesis & Manufacturing, Process Development) — [Compare](/compare/gland-pharma/simtrabps) - [Amneal Pharmaceuticals](/companies/amneal-pharmaceutical) (API Synthesis & Manufacturing, Process Development) — [Compare](/compare/amneal-pharmaceutical/gland-pharma) - [Delpharm](/companies/delpharm) (Process Development, Formulation Development) — [Compare](/compare/delpharm/gland-pharma) _Profile last updated: 2026-08-08T00:02:04.689Z. Profile facts may include AI-assisted enrichment._ Auto-generated by BioBM Editorial AI for machine-readable profile access.