Suppliers and packagers for generic pharmaceutical drug: Vosoritide

Vosoritide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938	NDA	BioMarin Pharmaceutical Inc.	68135-082-36	1 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12)	2021-11-19
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938	NDA	BioMarin Pharmaceutical Inc.	68135-119-66	1 KIT in 1 CARTON (68135-119-66) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-094-84) / .7 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-102-43)	2021-11-19
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938	NDA	BioMarin Pharmaceutical Inc.	68135-181-93	1 KIT in 1 CARTON (68135-181-93) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92) / .6 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-158-17)	2021-11-19

Vosoritide suppliers: contract manufacturing, key raw-material inputs, and IP-restricted production pathways

Last updated: May 24, 2026

Vosoritide (vosoritide acetate), the active ingredient in Yorvi (BioMarin), is supplied through tightly controlled manufacturing chains tied to BioMarin’s drug-substance and drug-product systems. The supplier set is materially constrained by (1) the peptide nature of the API, which drives specialized GMP synthesis and purification, and (2) regulatory and IP controls that typically limit equivalency manufacturing until patent and regulatory entry barriers clear.

Which companies supply vosoritide (API and drug product) for Yorvi?

Featured snippet: The practical supplier universe for vosoritide is dominated by BioMarin and its named contract development and manufacturing partners for peptide API and sterile drug product. Public “supplier” visibility is uneven because peptide sourcing often sits inside NDAs and because FDA CMC listings do not consistently identify all upstream peptide-synthesis and purification vendors.

What “supplier” categories matter for vosoritide?

For procurement and risk control, break suppliers into:

• Drug substance (peptide/API) manufacturers: chemical synthesis, folding/purification, isolation, and peptide-spec QC
• Drug product (sterile injectable) manufacturers: aseptic fill-finish, lyophilization or solution handling (as applicable to the commercial dosage form), sterile filtration validation, container-closure system controls
• Raw-material suppliers: protected amino acids, coupling reagents, resins, solvents, buffer components for API processing, and excipients for final formulation
• Analytical/QC partners: peptide identity and purity panels (LC-MS, HPLC methods), residual solvent and impurity profiling, endotoxin and sterility testing, stability-indicating assays

Which suppliers are publicly named versus contractually hidden?

For peptide therapeutics, public records more commonly name:

• The NDA/BLA holder and the primary CMC manufacturing site(s)
• The sterilization/fill-finish site
• Periodic inspections or site listings in regulatory disclosures

Upstream peptide synthesis suppliers and excipient vendors are often not surfaced in a way that lets purchasers fully map the chain beyond the primary CMC sites.

What contract manufacturers and fill-finish sites produce vosoritide for commercial supply?

Featured snippet: Commercial supply for Yorvi is controlled by BioMarin’s registered manufacturing network, with sterile fill-finish performed by GMP sites listed in regulatory filings. Those sites function as the supplier-to-approval interface, even when work is executed through subcontractors.

How to interpret “manufacturing site” listings when buying vosoritide supply

A manufacturing site listing in an FDA product dossier typically reflects one or more of:

• Drug substance manufacturing and release testing for the API intermediates or final API
• Drug product manufacturing steps: compounding, sterilization, aseptic filling, lyophilized cake reconstitution processes, and release testing

For vosoritide, peptide API requires tight control of:

• Impurity profile (deamidation, truncation, deletion/addition errors)
• Correct primary sequence and structural integrity
• Batch-to-batch comparability of HPLC and LC-MS fingerprints

What raw materials and excipients are most constrained for vosoritide production?

Featured snippet: The most constrained inputs for vosoritide are peptide synthesis building blocks and regulated sterile drug-product excipients, since they impact purity, impurity set, and aseptic manufacturing consistency.

API-side constrained inputs (typical for peptide drugs)

Vosoritide peptide synthesis depends on:

• Protected amino acids used in stepwise coupling
• Coupling reagents and activators
• Resins and linkers for solid-phase synthesis
• Solvents used in deprotection, washing, and purification
• Reagents for salt formation (vosoritide acetate) and final isolation

Procurement sensitivity points:

• Protected amino-acid availability and lead times
• Batch traceability and impurity content in building blocks
• Solvent control for residual solvent specifications
• Compatibility of reagent lots with validated impurity acceptance criteria

Drug-product side constrained inputs (typical for injectable peptides)

Injectable peptide formulations require control of:

• Buffer components and pH adjusters
• Stabilizers that manage aggregation or degradation
• Sterile filtration compatibility
• Container-closure system selection that prevents adsorption

How do IP and FDA regulatory controls affect supplier eligibility for vosoritide?

Featured snippet: Even if a supplier has peptide synthesis capability, regulatory approval and patent status determine whether it can legally and practically manufacture for the approved commercial label, especially if entry depends on abbreviated pathways or litigation outcomes.

Which exclusivity and patent barriers matter for vosoritide entrants?

The supplier landscape changes after:

• Core composition of matter or method-of-use protections expire
• Any remaining formulation or manufacturing-process patents expire
• Exclusivity periods (including those tied to pediatric development, regulatory exclusivity, or market exclusivity) end

For suppliers, this affects:

• Whether a generic or biosimilar-like peptide copy can be approved through an abbreviated pathway
• Whether a contract manufacturer can take on production risk without a clear regulatory and litigation runway

What generic or biosimilar-style risks exist for vosoritide supply?

Featured snippet: Vosoritide is a small therapeutic peptide, not a monoclonal antibody. “Biosimilar” framing is usually less direct than for biologics. The commercial risk is more commonly about peptide copycats and regulatory comparability rather than typical biosimilar exclusivity frameworks.

What supplier changes follow a successful entry scenario?

If a competitor obtains regulatory approval for a follow-on:

• New drug substance manufacturing sites must produce API meeting the same or equivalent specifications
• New sterile fill-finish sites must match validated CMC controls
• Supply chains broaden from the originator’s network to additional validated GMP vendors

What does a practical vendor due-diligence pack for vosoritide look like?

Featured snippet: A compliant due-diligence pack for vosoritide suppliers focuses on peptide-specific CMC capability and proven performance under GMP with documented comparability.

Checklist for API and drug-product vendors

• GMP certificate and last two inspection outcomes for relevant peptide/aseptic operations
• Peptide synthesis capability: solid-phase synthesis, purification (prep HPLC), LC-MS identity assays
• Impurity control: method validation for truncation, deletion, deamidation, and related substances
• Salt formation controls for vosoritide acetate (or equivalent validated form)
• Sterile manufacturing: aseptic validation package, endotoxin and sterility testing method suitability
• Stability program and accelerated/long-term stability data supporting shelf-life claims
• Traceability: full batch genealogy down to key reagents where permitted
• Supply continuity: batch capacity, lead time, and contingency plans for constrained amino acids/excipients

Key Takeaways

• Vosoritide supply is dominated by BioMarin-controlled CMC manufacturers for peptide drug substance and sterile drug product; upstream suppliers are often hidden behind contract structures.
• Peptide-specific manufacturing constraints make API and fill-finish capability the decisive supplier criteria, not generic sterile chemistry capacity.
• IP and regulatory barriers determine whether additional contract manufacturers can supply a legally approved follow-on product and widen the vendor pool.

FAQs

1) Who are the contract manufacturers listed for Yorvi (vosoritide)?
The manufacturer-of-record and fill-finish sites are the primary publicly actionable supplier identities tied to regulatory listings; upstream vendors may not be named in accessible sources.

2) What GMP capabilities are required to manufacture vosoritide peptide API?
Solid-phase peptide synthesis, impurity-controlled purification, and peptide identity confirmation using validated LC-MS/HPLC methods.

3) What are the highest-risk inputs in the vosoritide supply chain?
Protected amino acids and peptide-synthesis reagents that affect impurity profiles, plus sterile formulation excipients and container-closure compatibility for injectable peptide stability.

4) Can contract manufacturers produce vosoritide for competitors before IP expiry?
If production is for non-infringing, non-commercial uses and does not support an approved competing product, the risk depends on patent coverage and planned regulatory pathway; commercial supply tied to an approved follow-on is typically constrained.

5) What changes when a follow-on vosoritide product is approved?
New validated API and aseptic drug-product sites enter the qualified supplier list, expanding capacity beyond the originator’s manufacturing network.

References

1. U.S. Food and Drug Administration. Yorvi (vosoritide) product information and regulatory materials. FDA website.
2. U.S. Food and Drug Administration. Orange Book and related FDA exclusivity/patent listings for Yorvi (vosoritide). FDA website.