| Listed site | cdmo | cdmo |
|---|
| Summary | Fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases. | Specialized CDMO offering custom polymer science, PEG chemistry, bioconjugation, and cGMP manufacturing services from early discovery through commercial scale, with 30+ years of expertise rooted in Shearwater Polymers and Nektar Therapeutics. |
|---|
| Services | - API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Recombinant Protein Manufacturing
- Microbial Fermentation
- Upstream Processing
- Downstream Processing
- Biologics Development & Manufacturing
- Process Development
- Formulation Development
- Quality Control Testing
- Stability Testing & Storage
- CMC Analytical Development
- CMC Regulatory Submission Support
| - CMC Analytical Development
- Analytical Method Development & Validation
- Formulation Development
- Process Development
- Stability Testing & Storage
- ICH Stability Studies
- Bioconjugation Services
- Small Molecule Development & Manufacturing
- Recombinant Protein Manufacturing
- Biologics Development & Manufacturing
- Technology Transfer
- CMC Regulatory Submission Support
|
|---|
| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
| - Small Molecule
- Biologics (Other)
- Biologics (Monoclonal Antibodies)
- Peptide
|
|---|
| Indications | - Oncology
- Immunology
- Metabolic
| Data not yet provided. |
|---|
| Locations | - Headquarters, Bengaluru, Karnataka, India
- Manufacturing, Hyderabad, Telangana, India
- Manufacturing, Vizag, Andhra Pradesh, India
- Manufacturing, Johor, Johor, Malaysia
| - Headquarters, Huntsville, Alabama, United States
- Manufacturing Facility, Arab, Alabama, United States
|
|---|
| Certifications | - FDA · Identifier: US FDA
- EMA · Identifier: EMA
- PMDA · Identifier: PMDA, Japan
- Health Canada · Identifier: Health Canada
- COFEPRIS · Identifier: COFEPRIS, Mexico
- ANVISA · Identifier: ANVISA, Brazil
- MCC · Identifier: MCC, South Africa
- TGA · Identifier: TGA, Australia
- MFDS · Identifier: Ministry of Food and Drug Safety (MFDS), South Korea
- NPRA · Identifier: NPRA, Ministry of Health, Malaysia
| - FDA · Identifier: FDA-registered operations
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|