Share This Page
Bulk Pharmaceutical API Sources for PYLARIFY
✉ Email this page to a colleague
Bulk Pharmaceutical API Sources for PYLARIFY
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Starshine Chemical | ⤷ Start Trial | 2023-05-5H05274 | ⤷ Start Trial |
| AKos Consulting & Solutions | ⤷ Start Trial | AKOS040746739 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk API Sources for PYLARIFY (Pylarify, PSMA I&T)
Summary:
Pylarify (Piflufolastat F-18) is a positron emission tomography (PET) imaging agent targeting prostate-specific membrane antigen (PSMA). Its active pharmaceutical ingredient (API) is Piflufolastat F-18. As a radiopharmaceutical, API sourcing involves specialized manufacturing conforming to Good Manufacturing Practice (GMP) standards, typically supplied by a limited group of approved vendors.
API Composition and Manufacturing
API Details:
- Chemical name: N-(5-[(18)F]fluoropentyl)norbornan-2-amine
- Radioisotope: Fluorine-18 (F-18)
- Function: Radiolabeled ligand targeting PSMA
- Half-life of F-18: Approximately 110 minutes
API Manufacturing Challenges:
- Production of F-18 Nucleophilic Displacement reactions, often in automated synthesizers.
- Synthesis involves complex radiochemistry, requiring specialized facilities.
- API often supplied as a precursor labeled with F-18, with short shelf life.
Major API Suppliers for PYLARIFY
| Supplier Company | Location | Capabilities | Notes | Estimated Delivery |
|---|---|---|---|---|
| Cardinal Health | United States | GMP-grade F-18 synthesis kits, radiochemistry services | Approved under appropriate licensing | Same-day or next-day depending on needs |
| PETNET Solutions | United States | Production of F-18 radiotracers, customization for GMP standards | Established provider for PET compounds | Same-day |
| IRE ELiT (part of IRE Health) | Spain | F-18 synthesis, GMP compliant radiochemistry services | EU GMP accreditation | Same-day |
| Jubilant Radiopharma | United States | Radiochemistry facilities capable of F-18 synthesis | Large-scale manufacturing | Same-day |
Note: The F-18 isotope itself is produced at cyclotron facilities, typically shared infrastructure, and supplied to radiopharmacies and radiochemistry providers.
Key Considerations in API Sourcing
- Freshness: Due to radioactive decay, API must be delivered within hours of synthesis.
- Regulatory compliance: Suppliers must hold licenses from the FDA, EMA, or equivalent agencies.
- Quality standards: GMP certification ensures dose consistency, safety, and regulatory compliance.
- Supply chain constraints: Limited number of providers with radiochemistry capability; lead times are short to match decay characteristics.
Regulatory and Contract Market landscape
- The API for PYLARIFY is primarily sourced from providers with licensed radiochemistry facilities.
- The U.S. FDA grants approval for specific manufacturers under NDA and IND (Investigational New Drug) protocols.
- Market exists for bulk quantities of F-18 labeled precursors, rather than bulk non-radioactive API, due to the short half-life.
Future Outlook
- Expansion of manufacturing capacity expected to meet increasing demand for PSMA PET imaging.
- Potential entry of new radiopharmaceutical producers with integrated cyclotron and radiochemistry facilities.
Key Takeaways
- API for PYLARIFY is F-18 labeled Piflufolastat, produced by specialized radiochemistry providers.
- Main suppliers include Cardinal Health, PETNET Solutions, IRE ELiT, and Jubilant Radiopharma.
- Short half-life requires rapid synthesis, delivery, and tight logistical coordination.
- Regulatory compliance and GMP certification are mandatory.
- The market is limited to a few experienced radiopharma providers, with capacity expansion underway.
FAQs
Q1: How is the F-18 API for PYLARIFY produced?
A: It is synthesized via nucleophilic substitution reactions with F-18 in automated radiochemistry modules at GMP-certified facilities.
Q2: Who supplies the API for commercial PYLARIFY?
A: Major providers are Cardinal Health, PETNET Solutions, IRE ELiT, and Jubilant Radiopharma.
Q3: What are the logistical considerations for API supply?
A: Due to F-18’s short half-life (110 minutes), API must be synthesized and delivered within hours of production.
Q4: Are there plans to increase API supply?
A: Yes, investments in new radiochemistry facilities aim to expand capacity as demand escalates.
Q5: Is the API for PYLARIFY licensed globally?
A: Mainly licensed in the U.S. and Europe; regulatory approvals vary by region and manufacturer.
References
[1] Food and Drug Administration (2022). PYLARIFY (Piflufolastat F-18) NDA. FDA.gov.
[2] European Medicines Agency (2023). PSMA PET radiopharmaceuticals. EMA.europa.eu.
[3] Radiopharmaceuticals Market Analysis (2023). MarketWatch.
More… ↓
