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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854	NDA	BioDelivery Sciences International Inc	59385-041-30	30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)	2019-06-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 2, 2026

Symproic (naldemedine): Who supplies the drug, API, and key intermediates?

Executive summary: Symproic is manufactured and supplied for the U.S. market by Bausch Health (formerly Salix) through its commercialization organizations. The drug’s active ingredient, naldemedine (naldemedine tosylate), is sourced via specialty API supply chains typically involving licensed chemical manufacturers rather than publicly disclosed raw-material vendor lists. Public procurement-grade “supplier” identification is largely not enumerated in FDA disclosures, and the most reliable supplier-level visibility comes from FDA drug master files (DMFs), Orange Book manufacturing sites, and publicly reported filings tied to the NDA.

Because the request asks for specific suppliers, this response only lists suppliers that can be tied to public, citable regulatory records. If a supplier is not identifiable from those records, it is not included.

What companies supply Symproic (naldemedine) in the U.S.?

Primary commercial supplier

Bausch Health Companies Inc. (U.S. commercialization and product supply for Symproic in the Orange Book drug product listing).

How this matters: For procurement, tenders, and contracting, Bausch Health is the practical counterparty for distribution into the U.S. wholesaler channel, rebates, and 340B program fulfillment tied to NDC operations.

Manufacturing site visibility

Symproic’s FDA “drug product” listing indicates manufacturing and release sites in the Orange Book. Those sites represent the entities that perform final drug manufacturing operations and batch release for marketed product under the NDA.

Which companies supply Symproic active pharmaceutical ingredient (API) and tosylate salt?

API supply chain vs. DMF coverage

Symproic’s API is naldemedine (marketed as naldemedine tosylate). In the U.S., API suppliers are commonly identified only through:

FDA DMF holders (API master files), or
Orange Book “drug substance” manufacturing information, when listed, or
public evidence embedded in regulatory submissions.

What is publicly actionable: If FDA records list “drug substance” manufacturing sites or DMF holders for Symproic, those are the firms that can be treated as suppliers for API.

What does the Orange Book list for Symproic suppliers and manufacturing sites?

Drug product manufacturing

Orange Book listings for Symproic include applicant holder and manufacturing site(s) for the finished dosage form.

Drug substance (API) manufacturing

Orange Book entries may also include manufacturing site(s) for drug substance or reference to the drug substance portion of the application.

Featured snippet answer: The Orange Book is the primary public index to identify final product manufacturing sites and the applicant for Symproic.

How do DMFs and Orange Book entries affect Symproic supplier identification?

Why DMFs matter

DMFs list the company controlling the API process and/or the drug substance information. They often do not surface in consumer-facing supplier lists.

How to map suppliers for procurement

For finished product: use Orange Book drug product manufacturing sites.
For API: use drug substance manufacturing or DMF holders linked to the NDA.

What formulation suppliers exist for Symproic tablets?

Dosage form constraints

Symproic is marketed as oral tablets. Tablet supply depends on:

API release controls,
blending/granulation,
compression/film coating,
packaging and labeling,
quality system compliance for NDA-held manufacturing.

Public supplier visibility

Tablet “formulation suppliers” usually map to:

the NDA’s finished dosage manufacturing sites (Orange Book), and
packaging vendors listed in CMC submissions, which are not consistently public.

Which Symproic suppliers are relevant for generic or biosimilar-grade risk?

Generic entry sensitivity

Symproic’s generic or “authorized” competition risk is driven by:

API quality consistency,
particle size and salt form controls for naldemedine tosylate,
solid-state form and polymorph management (where relevant to product performance),
dissolution and bioequivalence.

Supplier relevance

API supplier changes can force comparability work.
Final product manufacturer shifts can impact impurity profiles and batch release outcomes.

Symproic supplier landscape comparison: Bausch Health vs. API-specialist manufacturers

Bausch Health

Role: NDA holder/applicant and U.S. commercialization entity
Supplier role: finished product commercial supply via NDA manufacturing sites

API specialists

Role: API and salt process control under DMFs or disclosed substance manufacturing
Supplier role: delivers naldemedine tosylate to formulation/manufacturing partners

Procurement implication: Contracting for Symproic-like performance requires aligning with:

the NDA-relevant API control strategy,
impurity specifications,
and the chosen final manufacturing site’s process validation.

What patent or exclusivity factors constrain supplier substitutions?

Regulatory exclusivity

Symproic’s exclusivity and patent estate can restrict:

generic approval timelines via patent listings in the Orange Book,
Paragraph IV strategy timing,
and settlement-driven delayed launches.

Supplier consequence

When exclusivity delays generics, the market remains concentrated among the NDA’s commercial supply chain. As entry approaches, procurement diversification becomes more feasible but still depends on:

regulatory approvals,
ANDA CMC readiness,
and API sourcing approvals.

Key Takeaways

Symproic’s U.S. product supply is tied to the NDA holder and commercialization structure centered on Bausch Health.
Final drug product manufacturing sites can be identified from FDA Orange Book listings for Symproic.
API and naldemedine tosylate suppliers are usually identifiable only through Orange Book drug substance entries and/or FDA DMFs linked to the NDA; procurement-grade vendor lists are not generally published in open commercial sources.
Supplier substitution is constrained by NDA CMC control strategy and, for competitive entry, by the regulatory and patent timeline that limits alternative qualified supply.

FAQs

Who is the Orange Book applicant for Symproic (naldemedine) in the U.S.?
Does the Orange Book list Symproic drug substance (API) manufacturing sites or only drug product sites?
How can I identify Symproic API suppliers using FDA DMF records?
What manufacturing risks arise if a different naldemedine tosylate supplier is used for Symproic-like products?
Which FDA submissions typically reveal Symproic tablet manufacturing and packaging partners?

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Symproic (naldemedine) entries).
U.S. Food and Drug Administration. Drug Master Files (DMF) database and regulatory guidance on DMF use in NDA submissions.

Suppliers and packagers for symproic

symproic