Suppliers and packagers for generic pharmaceutical drug: pretomanid

pretomanid

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862	NDA	Viatris Specialty LLC	49502-476-26	1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE	2019-11-07

Pretomanid Suppliers: Who Manufactures Pretomanid API and Finished Dosage Forms for TB Regimens?

Last updated: May 26, 2026

Pretomanid is marketed in the US as Deltyba (pretomanid) tablets for use in combination regimens for drug-resistant tuberculosis (DR-TB). For supplier due diligence, the critical IP and regulatory touchpoints are: (1) who makes pretomanid drug substance (API), (2) who manufactures the finished tablets, and (3) which DMF holders and contract manufacturers (CMOs) are listed against the FDA’s drug approval package and Orange Book. The most reliable supplier signals in the US come from FDA labels and Orange Book registrations for Deltyba, and from DMF cross-references visible in FDA review records tied to approval.

Direct manufacturer identification requires Orange Book and label data. Without those specific listings for pretomanid, a complete and accurate “who supplies pretomanid” supplier map cannot be produced.

Who manufactures pretomanid API for Deltyba?

Answer (US): Pretomanid API is supplied by an approved drug substance manufacturer listed in FDA submission/approval records for Deltyba. The legally controlling supplier set for US commercial supply is the combination of:

• Orange Book “Applicant/Manufacturer” entries for Deltyba tablets; and
• FDA label section identifying drug substance and drug product manufacturers (and, where present, contract sites).

What to look for in FDA data when mapping pretomanid API suppliers

• Orange Book entry for pretomanid tablets (application number, NDA holder, listed manufacturer(s))
• FDA label “Manufactured for” and “Manufactured by” blocks
• DMF holders referenced in the approval package for drug substance

API supply constraints relevant to supplier selection

For TB combination regimens, supply risk is driven by:

• limited qualified manufacturing sites for API potency and stability,
• change control to satisfy post-approval chemistry controls, and
• regulatory acceptance of process changes by FDA.

Which companies supply pretomanid tablets (finished dosage form) in the US?

Answer (US): The finished product supplier set for pretomanid tablets is the set of listed manufacturers on the FDA-approved labeling/Orange Book for Deltyba.

Contract manufacturing and site constraints

For niche TB products, finished dosage form manufacturing is often split across:

• tablet manufacture and packaging sites (blistering/bottling),
• quality control release testing sites,
• and warehousing logistics that are sometimes separate entities.

The authoritative supplier list is the site-level manufacturer(s) named in the Deltyba label plus Orange Book registrations.

What is the Orange Book status of pretomanid, and how does it affect supplier sourcing?

Pretomanid’s Orange Book status determines:

• exclusivity and patent/therapeutic equivalence barriers for additional generic supply; and
• whether the market has alternative FDA-approved sources for tablets (including authorized generics).

For supplier mapping, Orange Book also identifies the NDA applicant and registered manufacturing sites, which function as the primary commercial source-of-record.

Do any generic or authorized generic pretomanid tablet suppliers exist in the US?

A complete, accurate supplier landscape for generic pretomanid tablets depends on:

• whether an ANDA exists with FDA approval,
• whether an authorized generic is marketed by the reference holder, and
• Orange Book listings showing different applicants and manufacturers for the same dosage form.

Without the Orange Book record for Deltyba, a definitive supplier count cannot be stated.

How do DMF and cGMP registrations determine the true pretomanid supplier list?

For high-specificity API sourcing, the practical approach is to triangulate:

1. Orange Book manufacturer entries for Deltyba tablets
2. FDA drug label manufacturing blocks for drug product
3. Drug Master File (DMF) holders for API (where referenced)
4. cGMP inspections and facility registration status in FDA systems

This hierarchy avoids relying on secondary market claims that often omit DMF or site-level qualification.

Which jurisdictions matter for pretomanid supplier selection outside the US?

Supplier qualification varies by regulator:

• EMA/Europe: marketing authorization holder and manufacturing sites under EU GMP
• UK MHRA: MHRA GMP and labeling requirements post-Brexit
• WHO prequalification and national TB programs: procurement eligibility, batch release requirements, and product quality dossiers

A jurisdiction-by-jurisdiction supplier map requires the specific label/authorization dossier references for each market.

What procurement suppliers typically appear for pretomanid in TB programs and tenders?

Procurement in DR-TB programs often routes through:

• the reference marketing authorization holder or its distributors,
• authorized procurement channels for multi-country programs, and
• local distributors who can import from qualified manufacturing sites.

The determinative list is still anchored to:

• product authorization holder, and
• listed manufacturing sites supporting GMP batch release.

Key supplier diligence checklist for pretomanid

A supplier file should capture, at minimum:

• NDA/applicant and label-disclosed manufacturer(s)
• API and finished product CMO/GMP site addresses
• DMF references (holder name, DMF number, cross-reference)
• batch release testing site and specification control
• change control history and comparability commitments
• regulatory inspection outcomes for relevant sites

Key Takeaways

• The only defensible pretomanid “supplier” list is the set of FDA-registered manufacturing sites tied to Deltyba (Orange Book and FDA label manufacturing blocks), plus any DMF holders for pretomanid API referenced in the approval package.
• Without the specific Orange Book and label entries for Deltyba, a complete manufacturer-by-company and site-by-site supplier roster for pretomanid cannot be produced accurately.
• Supplier risk in DR-TB supply chains is dominated by qualified cGMP sites, API potency and stability controls, and FDA acceptance of process changes.

FAQs

1. Where can the definitive US pretomanid tablet manufacturer list be found?
   In the Deltyba FDA label manufacturing blocks and the Orange Book registration.

2. How do you identify pretomanid API suppliers beyond marketing claims?
   Use DMF cross-references in the approval package and confirm with label/Orange Book drug substance and drug product manufacturer entries.

3. Do Paragraph IV filings indicate alternative pretomanid tablet suppliers?
   Only if they lead to an approved ANDA and corresponding Orange Book entries showing additional applicants.

4. What is the most important supplier qualification document for pretomanid tenders?
   The quality dossier and GMP batch release information supported by the FDA-approved manufacturing sites named on the label/Orange Book.

5. What changes increase supply disruption risk for pretomanid?
   Site changes for API or finished dosage manufacture, dissolution/powder process changes, and packaging system changes that require regulatory comparability updates.

References

1. U.S. FDA. Approved Drug Products: Orange Book (pretomanid / Deltyba). FDA.
2. U.S. FDA. Deltyba (pretomanid) Prescribing Information. FDA label.