Dificid: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138	NDA	Merck Sharp & Dohme LLC	52015-700-22	1 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21)	2020-02-18
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699	NDA	Merck Sharp & Dohme LLC	52015-080-01	1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE	2011-05-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Executive summary: Dificid (fidaxomicin) is marketed in the U.S. by Merck Sharp & Dohme (MSD) and is produced through vertically integrated, contract-manufacturing networks that cover (1) fidaxomicin API, (2) finished tablets (200 mg), and (3) global secondary packaging and distribution. The supplier map depends on whether the target is U.S. commercialization (Drug product supply), generic/contract manufacturing, or regulatory filings (DMFs, ASMFs, and Orange Book manufacturing sites).

Who supplies the fidaxomicin API for Dificid?

Direct answer: The fidaxomicin API supply chain for Dificid is typically sourced via API manufacturers holding DMFs/ASMFs that support Merck’s finished product and scale-up needs. Public-facing supplier visibility is highest when API sites are listed in regulatory disclosures tied to approved finished dosage applications and commercial supply chains.

How to identify API suppliers for Dificid

Best public signals used in the market:

FDA DMF/ASMF references in CMC sections tied to the finished drug application (where listed).
Commercial manufacturing site references in Orange Book listings for the approved dosage form.
Quality and inspection footprints that align with manufacturing authorization geography.
Contract manufacturing disclosures in filings that connect API and finished product sites to MSD supply.

Supply-chain reality: For complex, low-dosage, fermentation-derived macrocyclic antibacterials like fidaxomicin, the API supplier pool is narrow, and site-by-site information is concentrated in regulatory submissions rather than marketing materials.

Who manufactures the finished Dificid tablets (200 mg)?

Direct answer: Merck Sharp & Dohme (and its manufacturing network) is the approved U.S. marketer. The finished tablets are produced through manufacturing sites that are tied to the approved NDA and listed manufacturing configurations.

Which sites matter commercially

Primary tablet manufacturing (blending, granulation if used, compression/encapsulation format as applicable, tablet coating).
Film coating and finishing (if applicable to the tablet).
Batch release testing and stability storage.
Packaging line (bottle vs blister formats depending on market).

Why finished-product suppliers differ from API suppliers

Tablet manufacturing requires:

crystallization/purification consistency at API scale,
validated particle-size distribution and assay windows,
coating and dissolution performance tied to excipient suppliers.

That creates a second-tier vendor structure even when the API source is stable.

What are the key excipient and packaging suppliers for Dificid?

Direct answer: Dificid uses standard tablet excipient categories (binder/disintegrant/lubricant/coating excipients) and standard packaging components. Supplier disclosure for excipients and secondary packaging is usually not public at the brand level, so market mapping is usually performed through the finished drug manufacturing site and NDA/CMC vendor qualification practices.

Where excipient supplier information becomes visible

NDA/CMC sections (rarely published in full).
DMF cross-references for critical excipients (when submitted).
Cold chain and stability configuration is typically site-specific, not brand-public.

What packaging inputs typically change

Bottle liners, desiccants, and closure systems (bottle markets).
Blister substrate and lidding formulations (blister markets).
Cartoning and labeling vendors tied to distribution geography.

How can you map Dificid suppliers using the FDA Orange Book?

Direct answer: Orange Book listings provide the most actionable public trail for:

listed manufacturers (drug product applicants/labelers),
strength-specific manufacturing configurations,
and the marketing authorization structure behind Dificid’s tablets.

What to look for in Orange Book entries

Applicant/labeler (MSD or related).
Dosage form and strength (fidaxomicin 200 mg tablets).
Manufacturer names and related site identifiers where listed.
Patent-protected manufacturing or formulation disclosures (indirect, but helpful for supplier selection in generic/CCM work).

What suppliers support Dificid distribution in the U.S. and internationally?

Direct answer: Distribution is supported through:

MSD’s commercial logistics network, and
third-party logistics providers (3PLs) and regional wholesalers that handle warehousing, order fulfillment, and cold/stability-preserving storage.

Why distribution suppliers are not interchangeable

Even with the same tablets, distribution requires:

label compliance by market,
correct unit-of-sale configuration by SKU,
lot traceability and recall readiness.

This typically locks in a smaller set of approved logistics partners at each geography.

Which companies are involved in manufacturing networks for Dificid besides Merck?

Direct answer: Dificid’s production is generally supported by:

contract manufacturing organizations (CMOs) operating under MSD’s quality system,
and specialty packaging firms supporting labeled unit configurations.

But: without the specific Orange Book manufacturing site and NDA facility disclosures, naming non-Merck manufacturers at the company level is not reliable for high-stakes supply chain decisions.

How does supplier selection impact biosafety, GMP compliance, and litigation risk?

Direct answer: Supplier swaps and scale changes create risk for:

quality deviations (assay, impurities, dissolution),
batch release failures,
and regulatory compliance gaps (GMP inspections and data integrity).

What buyers and litigators watch

whether API and drug product sites share audit histories,
whether changes trigger FDA comparability requirements,
whether new sites create new inspection dates and compliance outcomes.

What generic and contract manufacturing risks exist if you need Dificid supply?

Direct answer: For a branded, patent-constrained product like Dificid, supply for competitors can be constrained by:

IP-protected process/formulation features,
controlled improvements that may be tied to specific manufacturing conditions,
and limited supplier qualification bandwidth due to low number of capable sites.

Supplier qualification gating factors

analytical method transfer readiness,
impurity profile equivalence (fidaxomicin has impurity sensitivity),
stability program compatibility with target packaging.

Supplier map summary for decision-making

Practical supplier categories to build a sourcing strategy:

Fidaxomicin API suppliers (DMF-linked, narrow supplier set).
Finished dose tablet manufacturing sites (MSD-linked, Orange Book/manufacturer-dependent).
Critical excipient and coating component suppliers (vendor qualified per tablet CMC).
Packaging vendors (bottle/blister substrate and closure systems).
Regional distribution partners (3PL and wholesalers with lot traceability).

Key Takeaways

Dificid supplier sourcing is anchored by Merck’s approved supply chain for API-to-tablet manufacturing and commercial distribution.
Publicly usable supplier identification is most reliable through Orange Book manufacturer listings and NDA-linked regulatory facility references.
For high-stakes supply or licensing work, mapping API vs. finished-dose vs. packaging is essential because roles and qualification constraints differ across tiers.
Supplier changes introduce GMP and release risk tied to fidaxomicin’s tight quality windows and stability requirements.

FAQs

Which manufacturing sites are listed for Dificid tablets in FDA approval records?
The most actionable site names are those appearing in Orange Book manufacturer listings tied to the approved dosage form and strength.
How do DMFs help identify fidaxomicin API suppliers for Dificid?
DMF/ASMF references link API facilities to the finished drug application’s CMC package and regulatory history.
Do Dificid excipient vendors change by market (bottle vs blister)?
Packaging format can change SKU-level components, while excipient qualification usually remains under the approved CMC system.
What are the main quality-critical parameters for supplier qualification of fidaxomicin tablets?
Assay/purity and dissolution behavior, plus tablet coating consistency and stability under the packaged configuration.
Who handles Dificid warehousing and distribution in the U.S.?
MSD’s commercial logistics network and approved 3PL/wholesale partners that support lot traceability and compliance by label configuration.

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
FDA. Drugs@FDA. (Dificid fidaxomicin product record, regulatory and labeling history). https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. Application and regulatory submission records and facility information via FDA databases (NDA-related references). https://www.fda.gov/drugs

Suppliers and packagers for Dificid

Dificid

Dificid (fidaxomicin) Suppliers: Who Manufactures the Active Ingredient, Finished Dosage, and Key Distribution Inputs