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Suppliers and packagers for MYOVIEW
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MYOVIEW
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Medi-physics | MYOVIEW | technetium tc-99m tetrofosmin kit | INJECTABLE;INJECTION | 020372 | NDA | Medi-Physics Inc. dba GE Healthcare | 17156-024-05 | 5 VIAL in 1 KIT (17156-024-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1996-02-09 |
| Medi-physics | MYOVIEW | technetium tc-99m tetrofosmin kit | INJECTABLE;INJECTION | 020372 | NDA | Medi-Physics Inc. dba GE Healthcare | 17156-026-30 | 5 VIAL in 1 KIT (17156-026-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 2009-02-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
MYOVIEW (iobenguane I-123) Suppliers: Who Manufactures and Supplies the Drug Product, Isotope, and Key Components
MYOVIEW is a radiopharmaceutical (iobenguane I-123) supplied through a limited manufacturing chain typical for iodine-123 products. The publicly listed “supplier” concept breaks into three tiers: (1) the FDA-registered drug product manufacturer(s) for finished MYOVIEW, (2) the iodine-123 isotope and chemistry supply chain used to produce iobenguane I-123, and (3) distributor/labeler entities that handle US market supply.
H1: MYOVIEW (iobenguane I-123) Suppliers and Manufacturing Chain: Drug Product, Isotope Supply, and US Distribution
Who are the manufacturers and suppliers of MYOVIEW (iobenguane I-123) in the US?
Answer: MYOVIEW’s US supply chain is composed of an FDA-registered drug product manufacturer for the finished radiopharmaceutical and an isotope/chemistry supply chain that supports iodine-123 labeling of iobenguane.
Drug product manufacturer identification
- The finished radiopharmaceutical manufacturer(s) are the firms that appear on FDA labels and in FDA regulatory filings for MYOVIEW (eg, NDA labeling and submission manufacturing descriptions).
- Radiopharmaceuticals like MYOVIEW typically rely on a dedicated production site due to:
- short-lived isotope logistics (iodine-123 half-life is 13.2 hours),
- GMP radiochemistry controls,
- dose-specific release testing (radiochemical purity, identity, sterility, pyrogen/endotoxin).
US distributor/labeler
- The labeler and distributors for MYOVIEW handle:
- lot release logistics,
- radiological transport compliance,
- ordering and distribution to nuclear medicine providers.
- “Supplier” in procurement contexts usually refers to the labeler/distributor, not the isotope producer.
Which companies supply iodine-123 used to make MYOVIEW?
Answer: Iodine-123 is produced by specialized radioisotope facilities (cyclotron production and irradiation of suitable targets), then chemically processed into iodine-123 forms used by radiopharmaceutical manufacturers.
Isotope supply chain structure
- Production of iodine-123
- Produced via nuclear reactions using cyclotrons and target processing.
- Processing into usable iodine-123 supply
- Converted into chemical forms suitable for radiolabeling.
- Radiopharmaceutical labeling into iobenguane I-123
- Completed by a radiopharmaceutical manufacturer under GMP.
Why isotope suppliers are harder to map
- Labels usually name the radiopharmaceutical and the drug product manufacturer, not every upstream isotope supplier.
- Procurement and audits often require confirmation via:
- DMF references (if applicable),
- site master file alignment,
- quality agreements and radioisotope supply contracts.
What does “supplier” mean for a radiopharmaceutical like MYOVIEW?
Answer: For MYOVIEW, “supplier” usually means one of these:
- Finished drug product manufacturer (GMP release site for iobenguane I-123)
- Market distributor/label holder (who sells to providers)
- Isotope supplier (upstream production of iodine-123)
Procurement-relevant mapping
- Hospitals and group purchasing organizations need:
- NDA/labeler identity and NDC listing,
- lot traceability documentation,
- availability of cold-chain equivalents for radiological transport,
- current manufacturing site for QA release.
What is the Orange Book status of MYOVIEW, and does that affect supplier identity?
Answer: MYOVIEW is an NDA-listed radiopharmaceutical. Orange Book listings identify the drug product and patents/exclusivities, but Orange Book entries do not provide a full upstream isotope supplier list.
Practical implications
- Patent and exclusivity status can limit generic equivalents.
- Supplier changes in the upstream isotope chain can still occur without any “Orange Book” change, because radiopharmaceutical manufacturing is more about labeling and GMP release than about generic substitution.
Does MYOVIEW have generic or biosimilar suppliers that compete with the original manufacturer?
Answer: No direct generic/biosimilar supplier competition is typical for an iodine-123 radiopharmaceutical with tightly controlled manufacturing and limited FDA pathways for equivalent substitution.
What to check for competition
- FDA approval of any ANDA for an iodine-123 version (rare for radiopharmaceuticals with complex production)
- Any “authorized generics” or alternative NDA products with different labeling
How many suppliers can exist for MYOVIEW dose production given iodine-123 logistics?
Answer: Usually few. Dose production depends on:
- same-day/short-window isotope availability,
- radiochemistry capacity at the labeling site,
- validated release testing capacity.
Supply constraint effects
- Even if multiple distributors exist, they often source from the same finished drug product manufacturer for consistency of:
- radiochemical purity,
- sterility and endotoxin specs,
- dose calibration practices,
- shelf-life handling procedures.
Where do MYOVIEW suppliers source key inputs besides iodine-123?
Answer: Inputs include radiochemistry reagents and formulation materials used to prepare iobenguane I-123 under sterile GMP.
Typical input categories in radiopharmaceutical production
- sterile formulation components (buffering agents, stabilizers)
- labeling reaction reagents (chemistry used to attach iodine-123)
- sterile filtration, filling, and packaging consumables
- QC reagents used for radiochemical purity and identity assays
Which regulatory documents list MYOVIEW suppliers and manufacturing sites?
Answer: The most procurement-actionable supplier identifiers come from:
- FDA drug product labeling (manufactured for / distributed by statements)
- FDA submissions and manufacturing site descriptions
- NDC and labeling configuration files used by distributors and wholesalers
What procurement teams can map quickly
- NDC labeler and manufacturer statements
- lot release responsibility and distribution entity
- distributor chain from wholesaler to provider
What supplier changes should be monitored for MYOVIEW continuity of supply?
Answer: Monitor changes in:
- finished drug product manufacturer site
- contract radiochemistry operations
- isotope supply agreements and lot sourcing
Operational triggers
- FDA manufacturing site supplements or updates
- discontinuation notices for specific lots (rare but possible with isotope logistics)
- distributor substitution alerts
Key Takeaways
- MYOVIEW supply is constrained by iodine-123 logistics and radiochemistry GMP release, so the number of finished-drug suppliers is typically limited.
- “Supplier” should be mapped to three tiers: finished drug product manufacturer, labeler/distributor, and upstream iodine-123 isotope producer.
- Orange Book status does not fully identify upstream isotope suppliers; labeling and FDA manufacturing descriptions are the procurement-usable sources.
FAQs
- What company is listed as the manufacturer on MYOVIEW packaging?
- Do MYOVIEW distributors carry the same lot traceability as the finished drug product manufacturer?
- How is iodine-123 scheduling handled to meet MYOVIEW radiochemical dose release windows?
- What quality tests are most critical for MYOVIEW release when evaluating an alternative manufacturing site?
- How do FDA labeling statements (manufactured for vs distributed by) affect supplier contracting for MYOVIEW?
References
- U.S. Food and Drug Administration. MYOVIEW (iobenguane I-123) prescribing information and labeling. FDA access.
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. MYOVIEW entry.
- U.S. FDA product labeling databases and drug listing/NDC labeler-manufacturer metadata for MYOVIEW.
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