Last updated: May 28, 2026
PIFELTRO’s US commercial supply is produced under FDA-reviewed manufacturing controls tied to FDA drug-product inspections and labeling. The supplier picture breaks into three layers: doravirine active pharmaceutical ingredient (API) supply, key intermediate supply, and finished-dose (film-coated tablet) manufacturing and packaging.
Who are the manufacturers and suppliers for PIFELTRO (doravirine) tablets?
Answer: PIFELTRO’s tablet manufacturing and packaging suppliers are the firms listed in FDA drug labeling/manufacturing sections and on the Orange Book (where applicable). API suppliers are identified through the DMF/EDMF network and FDA inspection datasets tied to the approved marketing authorization.
Finished-dose (drug product) suppliers
PIFELTRO is supplied as oral tablets. The drug-product “manufactured for” and “manufactured by” entities in the US label define the finished-dose suppliers responsible for commercial release.
API and intermediate suppliers
Doravirine API and key intermediates are sourced via DMF/EDMF holders and contracted chemical manufacturers. These suppliers can differ by process technology (route, impurity profile controls, polymorph control) and by site qualification.
What API supplier supplies doravirine for PIFELTRO?
Answer: The API supplier(s) for doravirine are the DMF/EDMF holders associated with doravirine used in PIFELTRO, and the specific manufacturing sites approved for the API specifications.
How to map doravirine API suppliers to PIFELTRO
- Identify doravirine DMF/EDMF referenced by PIFELTRO’s NDA.
- Extract listed manufacturing sites for API release and for additional steps (crystallization, micronization, drying).
- Cross-check the finished-dose label for the “manufactured for/manufactured by” firm that holds release responsibility for tablets.
Which intermediates are suppliers for the doravirine synthesis used in PIFELTRO?
Answer: Intermediate suppliers are the contract chemical manufacturers producing the doravirine synthetic building blocks that feed the API crystallization/purification steps under the referenced DMF/EDMF. These are not always named on the public label and are usually identifiable only through DMF/EDMF content.
Typical intermediate categories in doravirine routes
- Core heterocycle formation and side-chain installation intermediates
- Protected amine/aryl intermediates used to control impurities
- Chlorination/fluorination and coupling intermediates where process impurity limits are set
What does the PIFELTRO Orange Book listing show about suppliers?
Answer: The Orange Book identifies the approved active ingredient and dosage form strength and, where disclosed, the NDA holder(s). It does not reliably list API/plant suppliers in a single consolidated place like a procurement database, but it helps anchor the NDA and formulation record to map to DMF and manufacturing-site references.
Which company supplies PIFELTRO in the US market?
Answer: PIFELTRO is marketed in the US under a branded NDA with a single drug sponsor. US market responsibility sits with the NDA holder and the contract manufacturing sites listed in labeling and FDA inspection records.
Are there multiple manufacturing sites for PIFELTRO tablets?
Answer: Multi-site supply is common for tablet products due to continuity-of-supply, but the number and identity of approved sites are determined by FDA-approved manufacturing supplements and current Good Manufacturing Practice (cGMP) status. The definitive list is the set of manufacturing sites referenced in labeling and FDA approval history for the specific NDA/strength.
What are the key supply-chain risk points for PIFELTRO manufacturing?
Answer: The main risk points are API site qualification, step-specific impurity control (particularly during key coupling and crystallization stages), and packaging line constraints for tablets.
Risk points by layer
API layer
- DMF/EDMF approved site reliance
- Scale-up batches and impurity qualification tied to the approved process
Drug product layer
- Compression and film-coating line availability
- Packaging line capacity and stability-control storage conditions
How do suppliers change if PIFELTRO is reformulated or if tech transfer occurs?
Answer: Tech transfer can add additional approved manufacturing sites, but it does not automatically change supplier identity unless FDA manufacturing supplements are approved for:
- API site additions (DMF/EDMF amendments)
- Tablet manufacturing site transfers
- Packaging site changes
Key Takeaways
- Supplier mapping for PIFELTRO splits into API/DMF/EDMF holders and drug-product tablet manufacturers listed in FDA labeling and manufacturing sections.
- The most reliable public anchors are FDA label manufacturing statements and the Orange Book NDA record; API/ intermediate suppliers require DMF/EDMF linkage to the referenced doravirine submission.
- Supply-chain risk concentrates on API site approval status, process-specific impurity controls, and tablet coating/packaging capacity.
FAQs
- Does PIFELTRO use a single doravirine API supplier or multiple sites?
- What FDA records identify the doravirine DMF/EDMF tied to PIFELTRO?
- Which tablet manufacturing steps (compression, coating, packaging) drive PIFELTRO supply constraints?
- How do Paragraph IV or generic entrants affect PIFELTRO supplier operations?
- Are PIFELTRO packaging suppliers tied to specific NDA labeler/packager roles?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- PIFELTRO (doravirine) Prescribing Information, current US label. U.S. Food and Drug Administration (accessed via FDA label repository).
