Suppliers and packagers for BIKTARVY

BIKTARVY

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	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	A-S Medication Solutions	50090-6247-0	30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)	2018-02-07
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	Gilead Sciences, Inc.	61958-2501-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1)	2018-02-07
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	Gilead Sciences, Inc.	61958-2501-2	7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2)	2018-02-07
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	Gilead Sciences, Inc.	61958-2501-3	30 TABLET in 1 BLISTER PACK (61958-2501-3)	2018-02-07
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	Gilead Sciences, Inc.	61958-2501-5	30 TABLET in 1 BLISTER PACK (61958-2501-5)	2018-02-07
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	Gilead Sciences, Inc.	61958-2505-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2505-1)	2021-10-07
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251	NDA	Gilead Sciences, Inc.	61958-2506-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2506-1)	2024-10-08

Suppliers and packagers for BIKTARVY

Last updated: April 25, 2026

Who Supplies BIKTARVY’s Drug Substance, Drug Product, and Key Materials?

BIKTARVY is a fixed-dose combination (FDC) antiretroviral regimen containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF). The formulation is marketed by Gilead Sciences in the US. The supply chain for such products typically spans (1) active pharmaceutical ingredients (APIs) and (2) finished-dose manufacturing through contract manufacturing organizations (CMOs).

However, no authoritative supplier list (named manufacturers for each API and the finished-dose site(s)) is provided in the information available in this session, and producing names would risk inaccuracy.

What’s directly supportable from available information

• Product: BIKTARVY (bictegravir / emtricitabine / tenofovir alafenamide)
• Marketing authorization holder (US): Gilead Sciences (as brand owner and commercial sponsor)
• Component identities:
  • Bictegravir
  • Emtricitabine
  • Tenofovir alafenamide

What cannot be stated accurately here

• Named API suppliers for bictegravir, emtricitabine, and tenofovir alafenamide
• Named finished-dose suppliers (tablet/capsule manufacturing and packaging sites)
• Named suppliers of key excipients, coating systems, or blister/bottle packaging for BIKTARVY

BIKTARVY Supply Chain Map (What would be populated with verified sources)

Supply layer	Item category	Specific items for BIKTARVY
APIs	Drug substances	Bictegravir, Emtricitabine, Tenofovir alafenamide
Finished product	Dosage form manufacturing	BIKTARVY tablets + packaging
Inputs	Excipients, materials	Tablet excipients, coating components, packaging materials

Key Takeaways

• BIKTARVY is a 3-drug FDC: bictegravir + emtricitabine + tenofovir alafenamide.
• Gilead Sciences is the US brand sponsor, but named supplier/manufacturer lists for APIs and finished-dose manufacturing are not present in the available data here.
• Any named supplier claims without verified regulatory or corporate documentation would not meet accuracy requirements.

FAQs

1. Who supplies BIKTARVY?
   The brand is marketed by Gilead Sciences, but specific contracted supplier/manufacturing site names are not provided in the available information here.

2. Which APIs are in BIKTARVY?
   Bictegravir, emtricitabine, and tenofovir alafenamide.

3. Are BIKTARVY APIs sourced from the same supplier?
   Fixed-dose products often use multiple API sources, but specific supplier assignments are not available here.

4. Who manufactures the finished BIKTARVY tablets?
   Finished-dose manufacturing is performed by Gilead and/or contract manufacturers, but named manufacturing sites are not available in the available information here.

5. Where can verified supplier lists be found?
   Supplier/manufacturing details are typically disclosed through regulatory filings and product labeling, but no such source text is included in this session.

References

[1] No citable sources were provided in the available input for named BIKTARVY suppliers (API or finished-dose).