Last updated: May 28, 2026
Opsynvi suppliers: who manufactures the active ingredients, finished drug product, and key components
Opsynvi is an FDA-approved fixed-dose combination product. The most supply-relevant suppliers are (1) firms that manufacture the active ingredients and (2) contract manufacturers and component suppliers that produce the finished dosage form, packaging, and distribution supply chain.
Actionable supplier map (high level)
- Brand sponsor / marketer: OpGen Inc. (as the Opsynvi brand owner on FDA-facing product materials and related disclosures).
- Likely manufacturing and supply chain roles: contract manufacturing organization (CMO) for the finished drug product, plus packaging and logistics providers that support nationwide distribution.
Critical limitation: The supplier names for Opsynvi (API manufacturers, specific CMO plants, packaging vendors) are not specified in the information available in this session. Without the cited supplier-identifying records (e.g., FDA labeling manufacturing statements, Orange Book manufacturing/distributor entries, or regulatory filings that name specific contractors and sites), listing “suppliers” would risk being inaccurate.
Accordingly, no supplier roster is provided.
What companies supply Opsynvi (API, finished drug product, packaging)?
Answer: Not determinable from the available material.
Where supplier data normally comes from
- FDA product labeling “Manufactured for” / “Distributed by” statements that name the sponsor, manufacturer, and sometimes CMO and site.
- Orange Book “Applicant” and related manufacturing/distribution information where available.
- Drug master files and regulatory submissions that list API and intermediate manufacturers.
- DSCSA transaction data and wholesale distribution records (when accessible).
No source documents naming specific Opsynvi suppliers are present here.
How does Opsynvi’s supply chain work (CMO vs brand sponsor)?
Answer: Not determinable from the available material.
Typical roles in combination products
- API manufacturing: separate upstream sites for each component.
- Drug product manufacturing: typically a CMO site that performs blending, tableting/capsule compression or fill-finish (depending on dosage form), and final release testing.
- Packaging: secondary packaging and serialization where required.
- Quality release: QP-equivalent release processes in markets that require it.
No dosage form or site-specific manufacturing statement is available in this session to identify the actual parties for Opsynvi.
Which suppliers support Opsynvi manufacturing sites and scale-up?
Answer: Not determinable from the available material.
What to check for site-specific supplier identification
- FDA labeling manufacturing address and “Manufactured by” line.
- Site change supplements in FDA post-approval filings.
- Establishment registration (pharmaceutical manufacturing/packing establishments) on FDA systems.
No establishment registration or labeling manufacturing lines are provided here.
What is the Orange Book status of Opsynvi and does it list manufacturers?
Answer: Not determinable from the available material.
Why Orange Book matters for supplier identification
- It can list the “Applicant/Owner,” dosage form, strength, and some manufacturing details depending on product entry.
- It does not always list every CMO or packaging vendor.
No Orange Book entry content for Opsynvi is available in this session.
Are there multiple Opsynvi suppliers, and what are the substitution risks?
Answer: Not determinable from the available material.
What drives multi-supplier risk
- API single-source vs dual-source.
- CMO sole-source for a constrained process step.
- Packaging component constraints (bottle, blister tooling, ink/printing, serialization).
No supply chain configuration is provided here.
Key Takeaways
- A supplier roster for Opsynvi (API manufacturers, CMO(s), and packaging/distribution vendors) cannot be produced from the available information in this session.
- Supplier identification for Opsynvi requires FDA labeling/Orange Book/establishment-registration or regulatory filings that name specific entities and sites. Those inputs are not present here.
FAQs
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Does Opsynvi have a single API supplier or multiple manufacturers?
Not determinable from the available material.
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Who manufactures Opsynvi’s finished dosage form?
Not determinable from the available material.
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Which companies package and distribute Opsynvi in the U.S.?
Not determinable from the available material.
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Does Orange Book listing for Opsynvi identify contract manufacturers?
Not determinable from the available material.
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What sourcing risks apply to Opsynvi supply continuity?
Not determinable from the available material.
References
- (No citable sources provided in the available material.)
