| Listed site | cdmo | cdmo |
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| Summary | India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance. | 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. |
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| Services | - Formulation Development
- Process Development
- Technology Transfer
- CMC Regulatory Submission Support
- CMC Analytical Development
- Stability Testing & Storage
- Quality Control Testing
- Oral Solid Dosage Manufacturing
- Ophthalmic Manufacturing
- Inhalation & Nasal Dosage Manufacturing
- Topical & Semi-Solid Manufacturing
- Vial Filling
- Lyophilization (Freeze Drying)
- Sterile Fill-Finish & Aseptic Manufacturing
- API Synthesis & Manufacturing
| - 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
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| Modalities | - Small Molecule
- Biologics (Other)
| - Small Molecule
- Biologics (Other)
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| Indications | - Respiratory
- Dermatology
- Ophthalmology
| Data not yet provided. |
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| Locations | - Sterile Manufacturing Facility, Haridwar, India
| - 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
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| Certifications | - WHO · Identifier: WHO-GMP
- FDA · Identifier: USFDA
- EMA · Identifier: EU-GMP
- TGA · Identifier: TGA
| - FDA · Identifier: USFDA
- MHRA · Identifier: MHRA
- EMA · Identifier: EMA
- ANVISA · Identifier: ANVISA
- TGA · Identifier: TGA
- BGV Hamburg · Identifier: BGV
- WHO · Identifier: WHO
- Health Canada · Identifier: Health Canada
- MCC · Identifier: MCC
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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