Suppliers and packagers for generic pharmaceutical drug: oteseconazole

oteseconazole

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888	NDA	Mycovia Pharmaceuticals, Inc.	74695-823-18	1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACK	2022-07-11

Suppliers and packagers for generic pharmaceutical drug: oteseconazole

Last updated: May 26, 2026

OTESECONAZOLE suppliers: who manufactures active ingredient and finished dose, and what supply-chain risks matter

Who supplies oteseconazole API and how is it sourced for US launches?

No complete, verifiable supplier map for oteseconazole API and finished-dose drug product is available in the information provided.
Without Orange Book manufacturer listings, FDA drug-substance/drug-product registrations, or publicly confirmed procurement disclosures tied to oteseconazole’s NDA/approval, a supplier list cannot be produced accurately.

What data sources typically identify oteseconazole manufacturers (and why they’re required)

To name “suppliers” with defensible specificity, the supplier set must be derived from at least one of the following:

• FDA Orange Book: listed applicant/holder plus drug product manufacturers and labelers
• FDA Drugs@FDA: applicant and sometimes manufacturing locations in approval documents
• CDER drug establishment registrations (NDC-level): firm-level drug-product manufacturing and listing
• DMF references (for API): letter-of-access and named DMF holder(s) tied to the approved NDA
• Patent prosecution and listings: manufacturing method disclosures tied to specific assignees (rarely sufficient alone)

Which companies are listed as manufacturers or labelers for oteseconazole in the FDA Orange Book?

No Orange Book manufacturer/labeler listings for oteseconazole are available in the information provided.
A manufacturer table cannot be generated without the NDA number, listed strengths, and the Orange Book entry details.

What would normally appear in a supplier table

A defensible supplier table would include:

• NDA number and approval date
• Brand name and dosage form
• Strengths and submission types
• Applicant/holder
• Drug product manufacturers (labeler/manufacturing site)
• Drug substance (API) sources (via DMF/DMR or DMF holder disclosures)

What suppliers provide oteseconazole drug product for clinical vs commercial supply?

No verified firm-level supply split (clinical vs commercial) is available in the information provided.
Delivering firm names for phase vs launch supply requires access to:

• clinical trial IMP/GMP batch release parties,
• the NDA’s manufacturing site designations,
• or procurement disclosures linked to site contracts.

How many API suppliers can make oteseconazole, and what are the typical manufacturing/IP constraints?

No API supply base size (number of qualified API suppliers) is available in the information provided.
For oteseconazole specifically, the number of API manufacturers depends on:

• the presence and accessibility of an approved DMF/ASR chain,
• whether multiple suppliers are qualified under the NDA,
• and whether API manufacturing involves protected intermediates and process patents.

Practical barriers that typically limit API competition

• DMF/letter-of-access exclusivity structure for the approved drug substance process
• Process controls and impurity specifications tied to the approved route
• GMP facility qualification, validation runs, and comparability constraints

Does oteseconazole rely on a single-source API supplier?

A single-source vs multi-source conclusion for oteseconazole cannot be produced without the NDA manufacturer chain and DMF/letter-of-access references. The required evidence is not present in the information provided.

What supplier-related risks exist for oteseconazole: shortages, lead times, and quality issues?

No firm-specific shortage history or inspection/consent-decree record is available in the information provided.
To quantify supplier risk for oteseconazole, supplier-level history is required:

• FDA drug shortage database entries tied to oteseconazole or its labeler,
• FDA inspection outcomes for the named manufacturing sites,
• and batch recall communications referencing the API manufacturer or fill-finish site.

How does supplier concentration affect oteseconazole generics and licensing?

A supplier-to-competition mapping for oteseconazole cannot be generated without knowledge of:

• approved drug substance source(s),
• whether generics rely on API from the same DMF chain,
• and whether license deals or settlements restrict supply.

Oteseconazole supply-chain summary table (not populated)

No supplier table is provided because the supplier facts (API/finished dose manufacturer names, labelers, sites, and evidence trails) are not present in the information provided.

Key Takeaways

• A supplier list for oteseconazole (API and finished-dose drug product) cannot be produced from the information provided.
• Defensible supplier identification requires Orange Book manufacturing/labeler entries, FDA establishment registrations, and/or DMF/letter-of-access references tied to the approved oteseconazole NDA.
• Without those source-linked data points, any company names would be speculative.

FAQs

1. What does the FDA Orange Book list for oteseconazole manufacturers?
2. Which oteseconazole NDA drug substance DMF holders are referenced in approval documents?
3. Who is the oteseconazole drug product labeler and where is it manufactured?
4. Are there multiple qualified API suppliers for oteseconazole under the approved NDA?
5. What firms handle oteseconazole sterile fill-finish or solid oral manufacturing (if applicable) in the FDA filings?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-27).
2. FDA. Drugs@FDA. (Accessed 2026-05-27).
3. FDA. Drugs Establishment Registration and Drug Listing (DERP). (Accessed 2026-05-27).