Last updated: June 9, 2026
Priftin (rifapentine) suppliers: who manufactures the API, key finished-dose partners, and what supply risks matter
Priftin is the brand of rifapentine (oral drug) used primarily for tuberculosis treatment. Supplier identification depends on (1) the rifapentine API producer(s) and (2) the drug product (finished-dose) manufacturer(s) that hold the marketing authorization and supply the US market. Without specific regulatory or listing data for the exact Priftin strength and market (US vs. ex-US), a complete, accurate “who supplies what” map cannot be produced.
Who supplies the rifapentine API used in Priftin?
Answer: Not determinable from the information provided.
What do API supplier findings normally come from?
For rifapentine, the most reliable supplier mapping in practice comes from:
- Drug Master File (DMF) references and listed API holders supporting NDA/ANDA submissions
- Contract manufacturing disclosures in regulatory filings
- Component-level disclosures in inspection and import records
- Public procurement and labeler/holder metadata tied to finished-dose NDCs
Which company manufactures Priftin finished tablets or capsules?
Answer: Not determinable from the information provided.
What identifies the finished-dose manufacturer
Finished-dose manufacturers are typically shown in:
- FDA label “Manufactured for/Distributed by” lines (US)
- NDC labeler and applicant/holder identifiers
- Regulatory product listings tied to the marketing authorization
What is the Priftin marketing authorization holder vs. the contract manufacturer?
Answer: Not determinable from the information provided.
Why the distinction matters for procurement
- The marketing authorization holder controls regulatory responsibility.
- The contract manufacturer controls capacity, QC release, and component supply risk.
- Procurement and substitution decisions hinge on both.
How many supply sources exist for rifapentine and Priftin dosage forms?
Answer: Not determinable from the information provided.
What “many vs. single source” changes commercially
- Single-source APIs raise lead-time and batch release risk.
- Multi-source APIs can reduce shortages but may increase variability in impurity profiles that affect stability and comparability.
Are there alternative rifapentine suppliers that can replace Priftin supply?
Answer: Not determinable from the information provided.
What to check for replacement capability
- Whether alternative products use the same salt form, polymorph, and dosage strength
- Whether they have different excipient systems that can impact bioavailability and manufacturing hold times
What supply chain risks affect Priftin availability in the US or EU?
Answer: Not determinable from the information provided.
Risk factors that typically drive rifapentine shortages
- API capacity constraints and raw material availability
- Quality system findings at key sites
- Regulatory holds impacting batch release
- Logistics bottlenecks for high-activity anti-tuberculosis actives
What are the key regulatory listings that show Priftin suppliers?
Answer: Not determinable from the information provided.
Listings that usually answer “who supplies”
- FDA Orange Book entries (where applicable) for manufacturer/applicant context
- Label “manufactured for” lines by strength and NDC
- FDA NDC Directory data and associated labeler records
How does Priftin supply compare with competing TB regimens using rifamycin class drugs?
Answer: Not determinable from the information provided.
What a supplier comparison normally includes
- API upstream producers and whether procurement is captive
- Finished-dose CMOs and site diversification
- Storage and distribution constraints by dosage format
Key Takeaways
- A complete supplier map for Priftin requires specific regulatory/NDC and labeler/API DMF-linked data by market and strength.
- The information provided is insufficient to produce a correct list of rifapentine API suppliers and Priftin finished-dose manufacturers.
FAQs
- How do I identify the API supplier for rifapentine in US filings?
- What does the NDC labeler field tell me about Priftin manufacturing sites?
- Where can I find Priftin “manufactured for” lines by strength and NDC?
- Does Priftin have multiple approved manufacturing sites in the same regulatory jurisdiction?
- How do supplier changes affect batch release, QC testing, and product availability?
References
- FDA Orange Book. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA NDC Directory. https://ndclist.com/ndc/
- FDA Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
