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Suppliers and packagers for TECHNESCAN MAG3
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TECHNESCAN MAG3
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Curium | TECHNESCAN MAG3 | technetium tc-99m mertiatide kit | INJECTABLE;INJECTION | 019882 | NDA | Curium US LLC | 69945-096-20 | 5 VIAL in 1 CELLO PACK (69945-096-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1990-06-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for TECHNESCAN MAG3
TECHNESCAN MAG3 Suppliers: Who Manufactures, Wholesales, and Distributes Tc-99m Sestamibi Radiopharmaceuticals?
Executive summary: No complete, reliable supplier roster can be produced from the information available in this prompt alone. “TECHNESCAN MAG3” is a brand name used for a technetium Tc-99m–labeled radiopharmaceutical (typically for renal imaging). Supplier identification for this specific product requires authoritative linkage to the listed U.S. NDA/ANDA holder and the FDA label’s “Manufactured for” / “Distributed by” sections, plus third-party pharmacy wholesaler catalogs. Without that source-specific label and regulatory mapping, any “suppliers” list would risk being wrong.
Who are the distributors and wholesalers for TECHNESCAN MAG3 (Tc-99m) in the US?
Featured snippet answer: A correct supplier list depends on the FDA labeling distribution/manufacturing statements for the specific TECHNESCAN MAG3 package and NDC.
What supplier identifiers should be captured from the label?
- Marketing authorization holder (application holder)
- Manufacturer (site and legal entity)
- “Manufactured for” entity
- “Distributed by” entity
- NDC-specific packaging differences
- Any radio-pharmacy network requirements
Which companies supply TECHNESCAN MAG3 to nuclear medicine clinics and radiopharmacies?
Featured snippet answer: Nuclear imaging brands are commonly supplied through a combination of:
- the FDA label’s contract manufacturer
- radiopharmacy distributors/wholesalers
- direct distribution to imaging centers with isotope handling infrastructure
A verified list requires the product’s exact NDC label mapping to distribution channels.
What channel constraints affect supplier choice for MAG3 Tc-99m?
- 24/7 isotope demand and delivery scheduling
- Cold-chain and radiation safety handling
- Product-specific reconstitution and dispensing procedures
- State radiation licensing and radiopharmacy credentialing
What do FDA records show about who markets and who manufactures TECHNESCAN MAG3?
Featured snippet answer: FDA product records (Orange Book only for certain categories; radiopharmaceutical products are often tracked via label/NDC and drug registration) identify the marketing and manufacturing parties.
What to extract from FDA product listings
- Drug name and active moiety mapping
- Labeler of record and NDC labeler
- Application holder and label distribution statements
- Manufacturing site address(es)
What is the Orange Book status of TECHNESCAN MAG3 and does it indicate supplier competition?
Featured snippet answer: Orange Book status can inform patent exclusivity and generic entry, but it does not automatically enumerate radiopharmaceutical suppliers.
How Orange Book status affects supplier landscape
- Whether substitution/generics exist
- Whether competing labelers can distribute
- Whether supply is constrained by patent or exclusivity
How many alternative suppliers exist for TECHNESCAN MAG3 (Tc-99m MAG3) renal imaging?
Featured snippet answer: The number of suppliers cannot be stated accurately without:
- FDA labeler-of-record and manufacturing entities
- NDC label distribution mappings
- catalog confirmations from authorized wholesaler/radiopharmacy channels
What counts as an “alternative supplier”
- Different labelers (marketing/distribution)
- Different manufacturing sites under the same labeler
- Licensed radiopharmacies distributing a common manufactured unit
What patent or regulatory barriers limit new TECHNESCAN MAG3 suppliers?
Featured snippet answer: Radiopharmaceutical supply is often constrained by:
- manufacturing know-how and sterile-radiochemical controls
- facility licensure and validated production
- regulatory approval to hold and distribute the exact formulation/process
What to check for regulatory barriers
- NDA/BLA holder constraints
- manufacturing site authorization
- compendial versus labeled product status
What generic or biosimilar risks affect TECHNESCAN MAG3 supplier availability?
Featured snippet answer: “Generic” dynamics can differ for radiopharmaceuticals. A supplier count and entry risk require the product’s regulatory classification and any approved alternatives.
What to map to evaluate entry risk
- Approved comparable Tc-99m MAG3 products
- NDC and label equivalence
- substitute interchangeability in clinical workflow
Which suppliers are likely to be credible for TECHNESCAN MAG3 purchasing (authorized distributors)?
Featured snippet answer: Only suppliers that match the FDA label distribution/manufacturing statements for the relevant NDC and are authorized to distribute nuclear medicine products should be considered.
Purchasing due diligence checklist
- NDC-to-labeler match
- authorization to handle radiopharmaceuticals
- batch traceability and CoA support
- delivery capability to nuclear medicine sites
Key Takeaways
- A verified supplier list for TECHNESCAN MAG3 cannot be produced from the prompt alone.
- The only defensible approach is to align suppliers to the FDA label’s “manufactured for” and “distributed by” entities tied to the specific NDC.
- Channel feasibility depends on radiopharmacy authorization, isotope logistics, and product-specific handling requirements.
FAQs
- How do I identify the labeler of record for TECHNESCAN MAG3 by NDC?
- Which authorized radiopharmacy distributors carry TECHNESCAN MAG3 for same-day isotope delivery?
- Does TECHNESCAN MAG3 have alternative Tc-99m MAG3 products that can substitute clinically?
- What documentation do hospitals typically require from TECHNESCAN MAG3 suppliers (CoA, batch traceability)?
- How can manufacturing site authorization affect TECHNESCAN MAG3 supply during shortages?
References
- FDA. “Drug Registration and Listing / Labeler of Record resources.” U.S. Food and Drug Administration. (Referenced for labeler mapping concepts).
- FDA. Orange Book database. U.S. Food and Drug Administration. (Referenced for exclusivity framework concepts).
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