| Listed site | cdmo | cdmo |
|---|
| Summary | Specialty CDMO offering formulation development, analytical services, and cGMP manufacturing for small molecules and biologics from preclinical through Phase 1 and commercialization. | 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. |
|---|
| Services | - Formulation Development
- CMC Analytical Development
- Stability Testing & Storage
- Process Development
- Quality Control Testing
- Technology Transfer
- Lipid Nanoparticle (LNP) Formulation
- Peptide Manufacturing
- HPAPI Manufacturing (High-Potency)
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Oral Solid Dosage Manufacturing
- Lyophilization (Freeze Drying)
- Vial Filling
- Sterile Fill-Finish & Aseptic Manufacturing
- CMC Regulatory Submission Support
- Prefilled Syringe (PFS) Filling
| - 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)
- mRNA
- Gene Therapy
| - Small Molecule
- Biologics (Other)
|
|---|
| Indications | Data not yet provided. | Data not yet provided. |
|---|
| Locations | - Headquarters / New Jersey Bioscience Center, North Brunswick, New Jersey, United States
| - 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 | Data not yet provided. | - 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
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|