Suppliers and packagers for TYMLOS

TYMLOS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743	NDA	Radius Health, Inc.	70539-001-02	1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01)	2017-05-01
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743	NDA	Radius Health, Inc.	70539-001-98	1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99)	2017-05-01

Suppliers and packagers for TYMLOS

Last updated: April 26, 2026

TYMLOS (abaloparatide) Suppliers: What the supply chain must cover

TYMLOS is an injectable parathyroid hormone–related protein (PTHrP) analog (abaloparatide) used for osteoporosis. For procurement and sourcing planning, “suppliers” must be mapped to four supply-chain layers: (1) active pharmaceutical ingredient (API) manufacture, (2) drug product (fill-finish and assembly), (3) key controlled components (device/pen and primary packaging), and (4) regulatory/quality-controlled release partners.

If a complete supplier list is required, the authoritative way is through the drug’s application records (FDA and partner regulators), which identify labeled manufacturers and facility roles (API vs finished drug vs packaging). Those records are not present in the prompt, so a complete supplier set cannot be produced without fabricating facts.

What counts as a “supplier” for TYMLOS?

1. API manufacturer (abaloparatide)
   Supplies the peptide API and is responsible for API GMP manufacture and release.

2. Drug product manufacturer (abaloparatide injection drug product)
   Supplies the finished sterile injectable drug product under GMP.

3. Fill-finish and device/pen ecosystem supplier
   Supplies sterile filling, syringe/needle components (if applicable), and the delivery device assembly (the TYMLOS pen system).

4. Primary packaging supplier
   Supplies components that directly contact the drug product (cartridges/syringes/closures) and the carton configuration used for distribution.

Without the underlying application/label and the manufacturing site disclosures, listing specific supplier names and addresses would not meet the accuracy standard needed for sourcing decisions.

Who is the market authorization holder (and therefore the de facto supply-chain orchestrator)?

TYMLOS is marketed in the US under the authorization of Radius Health, Inc. (now under Radius’s acquisition and integration structure). The sponsor/holder is the entity that manages regulatory obligations and typically contracts manufacturing and release with external GMP partners.

Where do authoritative supplier names come from for TYMLOS?

For branded injectables like TYMLOS, the supplier set that matters for procurement is extracted from:

• FDA label manufacturing site disclosures (drug product manufacturer and packaged by statements).
• FDA drug application facility and site roles (API manufacturing vs finished dosage vs packaging vs labeling).
• Device and pen component vendor disclosures when the device is treated as part of the drug product combination.

These elements are not provided in the prompt.

Supply-chain mapping framework you can use immediately (procurement-ready)

Even without names, procurement teams can structure RFQs and vendor qualification around the roles that are always required for TYMLOS:

Supply-chain layer	What procurement must source	GMP expectation	Typical document artifacts
API	Abaloparatide peptide and API intermediates	API GMP, validated synthesis, impurity control	DMF/CEP references, CoA, GMP certificates
Sterile drug product	Abaloparatide sterile injection formulation and aseptic processing	Sterile manufacturing and batch release	Batch records, sterility assurance, CoA
Fill-finish	Cartridge/syringe filling, labeling, secondary ops	Sterile fill-finish under GMP	Line clearance, container-closure validation
Device/pen	Pen mechanism components and assembly (if sourced separately)	Device-grade QA/QMS plus integration validation	Design history records, supplier change control
Primary packaging	Container-closure system	Compatibility and stability support	Extractables/leachables, stability protocol
Finished packaging	Cartons, leaflets/inserts	Labeling compliance and traceability	Artwork approvals, serialization steps

This is the checklist used to ensure that the chosen vendors can meet quality, regulatory, and timeline constraints for a controlled, sterile injectable product.

What you should expect in any complete TYMLOS supplier list

A complete supplier listing normally includes:

• 1+ API site(s) (abaloparatide)
• 1+ sterile drug product/fill-finish site(s)
• Packaging/labeling site(s)
• Device assembly site(s) (if treated as a distinct combination element)

The number of suppliers can be 2 to 6 across these layers depending on pandemic-era surge capacity, line qualification strategy, and component supply continuity.

Key Takeaways

• A “supplier” for TYMLOS must be mapped to API, sterile drug product/fill-finish, device/pen assembly, and primary packaging roles.
• A complete and accurate list of supplier names for TYMLOS requires extracting them from the FDA label and application manufacturing-site disclosures.
• The prompt does not contain the label/application data needed to name specific TYMLOS suppliers without risking incorrect attribution.
• Use a role-based vendor qualification framework to drive accurate RFQs and avoid gaps in sterile manufacturing, device integration, and container-closure responsibilities.

FAQs

1. Is the TYMLOS API supplier the same as the drug product manufacturer?
   Not necessarily. API sites and sterile fill-finish sites are commonly separate.

2. Does TYMLOS include a device supplier (pen system)?
   The administration system is part of the commercial product. Device component supply and assembly typically require validated integration.

3. What documentation proves a supplier can make TYMLOS-ready material?
   GMP certificates, CoA, relevant regulatory filings (DMF/CEP where applicable), and batch release documentation aligned to the authorized manufacturing process.

4. How many suppliers does a typical branded sterile injectable have?
   Often multiple across API, fill-finish, packaging, and device-related components, commonly 2 to 6 total sites by role.

5. Where can procurement teams reliably identify TYMLOS manufacturing sites?
   The US product label and the underlying FDA application manufacturing-site disclosures are the authoritative sources.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug label information for TYMLOS (abaloparatide). FDA.
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: TYMLOS (abaloparatide) product details and label. FDA.