Suppliers and packagers for sunlenca

sunlenca

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973	NDA	Gilead Sciences, Inc.	61958-3002-1	1 KIT in 1 CARTON (61958-3002-1) * 1.5 mL in 1 VIAL (61958-3004-1)	2022-12-22
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973	NDA	Gilead Sciences, Inc.	61958-3005-1	1 KIT in 1 CARTON (61958-3005-1) * 1.5 mL in 1 VIAL (61958-3004-1)	2025-03-18
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974	NDA	Gilead Sciences, Inc.	61958-3001-1	1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK	2022-12-22
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974	NDA	Gilead Sciences, Inc.	61958-3001-2	1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK	2022-12-22
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974	NDA	Gilead Sciences, Inc.	61958-3001-3	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3)	2022-12-22

SUNLENCA (lenacapavir) suppliers: who makes the drug substance, drug product, and key components powering commercialization

Last updated: May 26, 2026

Executive summary

• SUNLENCA’s active ingredient is lenacapavir, a capsid inhibitor for heavily treatment-experienced HIV patients.
• Public “supplier” visibility splits into (1) contract manufacturing for drug substance (API) and (2) contract manufacturing for drug product (DP) and packaging.
• Accurate identification of specific SUNLENCA suppliers (API sites, DP plants, and packaging vendors) requires Orange Book and CMC sourcing records tied to approved NDA/labeling and manufacturing site disclosures. Those supplier-specific facts are not present in the information provided here, so no definitive supplier list can be produced without risking incorrect assignments.

Which companies are listed as SUNLENCA suppliers (API and finished dose)?

Short answer: No supplier list can be stated from the information available in this prompt.

What “supplier” means in SUNLENCA procurement due diligence

• API (lenacapavir) manufacturer: contract or internal site producing the drug substance.
• Drug product manufacturer: site that formulates, fills, and finishes the final dosage form.
• Packaging and labeling: secondary packaging, kit components, and labeling partners.

What documents normally expose SUNLENCA suppliers

• FDA labeling “Manufactured for” line and related CMC summaries.
• FDA application reviews (NDA Chemistry/CMC) and launch/inspection data.
• Drug establishment registrations tied to the specific dosage form and strength.
• Commercial supply chain disclosures in licensing, procurement, or investor materials.

What suppliers make SUNLENCA drug substance (lenacapavir API)?

Short answer: Not determinable from the provided input.

API sourcing questions procurement teams track

• Is API manufactured under GMP for lenacapavir synthesis intermediates?
• Is the supplier single-source or dual-sourced for risk mitigation?
• Are there polymorph/particle-size or process-change constraints tied to regulatory comparability?

What suppliers manufacture and package SUNLENCA finished drug product?

Short answer: Not determinable from the provided input.

Manufacturing site scope teams typically verify

• Sterility assurance and container closure integrity (as applicable to the dosage form)
• Filler/syringe or tablet/capsule line compatibility (if relevant to formulation type)
• Serialized packaging and labeling compliance capacity

What do FDA submissions and label sections say about SUNLENCA manufacturers?

Short answer: Not determinable from the provided input.

Labeling fields that usually name manufacturers

• “Manufactured for” / “Distributed by”
• “Manufactured by” including facility name and address
• Storage and handling section that sometimes references packaging vendor context

How do supplier choices affect SUNLENCA supply risk and continuity?

Short answer: Not determinable from the provided input.

Supplier-specific risk levers

• Batch release dependencies (independent testing labs versus in-house QC)
• API lead times versus DP lead times
• Regulatory constraints on tech transfer and process changes

Key Takeaways

• A definitive, company-by-company list of SUNLENCA suppliers cannot be provided from the information in this prompt.
• Supplier identification for SUNLENCA requires manufacturer and facility facts from FDA labeling, establishment registrations, and CMC documentation tied to the approved NDA/DP/APIs.
• Any attempt to name suppliers without those source-backed facts risks incorrect procurement, licensing, or diligence outcomes.

FAQs

1. How can I confirm the actual SUNLENCA API manufacturer?
2. What label elements indicate SUNLENCA drug product and packaging contractors?
3. Where do I find SUNLENCA manufacturing site registration records?
4. Do SUNLENCA supplier changes require FDA comparability reporting?
5. What supply chain risks matter most for lenacapavir commercialization?

References

No sources were provided in the prompt to cite.