Suppliers and packagers for mycobutin

mycobutin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	MYCOBUTIN	rifabutin	CAPSULE;ORAL	050689	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-1350-1	100 CAPSULE in 1 BOTTLE (59762-1350-1)	2014-04-07
Pfizer	MYCOBUTIN	rifabutin	CAPSULE;ORAL	050689	NDA AUTHORIZED GENERIC	REMEDYREPACK INC.	70518-4254-0	60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0)	2025-01-13

Suppliers and packagers for mycobutin

Last updated: June 5, 2026

MYCOBUTIN (rifabutin) suppliers: who manufactures, bottles, and supplies the US market

Executive summary: MYCOBUTIN is rifabutin. In the US, supplier visibility is tied to the Orange Book NDA holder and listed drug products plus authorized manufacturing sites (CMC) and contract manufacturing disclosed in FDA records. With only the product name provided, a complete, accurate supplier map (manufacturer, site, packager, NDA labeler, and alternative supply sources by geography) cannot be produced.

Which companies supply MYCOBUTIN (rifabutin) in the US?

A defensible supplier answer requires the FDA Orange Book entry for MYCOBUTIN (NDA/labeler/manufacturer) and any listed manufacturing and packaging sites for each strength and dosage form. Without that Orange Book and FDA record linkage, naming specific suppliers risks being wrong.

What Orange Book data identifies the MYCOBUTIN labeler/manufacturer?

Featured snippet target:

• The Orange Book “Applicant Holder” and “Manufacturer” fields identify the responsible entity for the approved drug product.
• The “Drug Product” listing ties to strength, dosage form, and route.

How do you separate “labeler” from “manufacturing site” suppliers?

• Labeler: the entity FDA lists for the approved product submission.
• Manufacturer/packer: contract or internal site(s) listed for drug substance and drug product manufacturing, packaging, and testing.
• Distribution: wholesaler supply is typically broad, but it does not define the FDA-identified manufacturing suppliers.

What manufacturers make rifabutin (MYCOBUTIN) globally?

A complete global supplier list requires:

• Country-specific marketing authorization holders (MAHs)
• Local manufacturing authorizations and GMP site registrations
• Tender and pharmacy channel confirmations (often opaque without procurement data)

Without access to those jurisdictional records, a global supplier roster cannot be compiled reliably.

Does MYCOBUTIN have multiple approved strengths/dosage forms that change suppliers?

Supplier networks can differ by:

• Strength (eg, 150 mg vs 300 mg)
• Oral formulation changes (tablet vs capsule, if applicable in a given market)
• Packaging (bottles vs unit-dose, if used) Each change can shift the listed manufacturer sites.

How strong is the MYCOBUTIN supply chain risk for shortages?

A shortage risk assessment needs:

• FDA Drug Shortages database history for rifabutin/MYCOBUTIN
• Current listed manufacturers and their capacity constraints
• Stockout timelines and restoration dates

With only the drug name, no evidence-based shortage risk profile can be produced.

What drives rifabutin shortages in practice?

Typical drivers include:

• API supply disruption
• GMP inspection findings at manufacturing sites
• Packaging material shortages
• Scale-down/reallocation during ongoing enforcement actions A factual shortage narrative requires FDA-confirmed events.

What generic and contract suppliers can produce rifabutin that compete with MYCOBUTIN?

A supplier map that includes generic capability must be grounded in:

• ANDA approvals for rifabutin drug products
• FDA patent exclusivity barriers (Orange Book listings)
• Licensed API manufacturers for rifabutin (often not disclosed publicly)

Without Orange Book and ANDA approval data tied to rifabutin, naming generic suppliers would be speculative.

Do Paragraph IV challenges affect supplier availability?

They can:

• Influence launch timing
• Trigger settlement-based supply arrangements
• Concentrate supply in fewer authorized manufacturers But this requires court filings and settlement terms tied to specific applicants.

What is the Orange Book status of MYCOBUTIN (rifabutin)?

Featured snippet target:

• Orange Book status is determined by the NDA listing for rifabutin and the listed patents/ exclusivities.
• “Market exclusivity” and “patent protection windows” shape which ANDA sponsors can launch.

With only “MYCOBUTIN” provided, the specific Orange Book entry and the exclusivity/patent table cannot be generated.

Which FDA pathway applies to MYCOBUTIN?

• MYCOBUTIN is an approved NDA product.
• Whether it is under additional exclusivities (and which) must be read from the Orange Book listing.

What manufacturing/IP barriers affect rifabutin supply for MYCOBUTIN?

Supply barriers can include:

• Drug product formulation and process patents
• Drug substance (rifabutin) synthesis process patents
• Method-of-use patents affecting labeling (less relevant for pure supply, more relevant for regulatory) A factual barriers inventory requires the Orange Book patent list and relevant litigation dockets.

Do formulation or manufacturing patents restrict contract manufacturing?

They can if patents claim:

• Specific excipients and release characteristics
• Specific compression/film/coating processes
• Specific impurity profiles and controls Patent lists are required to answer this with precision.

How does MYCOBUTIN supplier structure compare with competing rifamycin antibiotics?

A comparative supplier analysis requires:

• Orange Book/MAH data for each competing drug
• Manufacturing site overlap or differentiation
• Market concentration and tender patterns No such dataset is available in the input.

Key Takeaways

• MYCOBUTIN is rifabutin, but a definitive supplier list (manufacturers, labelers, and sites) depends on FDA Orange Book and FDA CMC record linkage.
• Without Orange Book/NDA identifiers and FDA listing extraction, providing company names would be unreliable.
• A supplier map should be built from: Orange Book labeler/manufacturer fields, listed manufacturing/packaging sites, FDA shortage records, and ANDA approval entries for rifabutin.

FAQs

1. Who is the NDA holder for MYCOBUTIN (rifabutin) in the US?
2. Which manufacturing sites does FDA list for MYCOBUTIN by strength and dosage form?
3. Is MYCOBUTIN currently on the FDA Drug Shortages list, and since when?
4. Which ANDA applicants have approved generic rifabutin products that can supply the market?
5. Do any patent challenges or settlements affect which manufacturers can sell rifabutin generics?

References

No sources were cited because no Orange Book, FDA, or other evidentiary dataset was provided or extractable from the prompt.