Molecules / Tenofovir Alafenamide

Tenofovir Alafenamide API manufacturers

CAS 379270-37-8 ATC J05AF13 Updated 9 July 2026
24
manufacturers with an active filing 17 of them hold a US DMF or a CEP
138
finished-dose makers across 44 regulators
Showing 20 of 24 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Lupin

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tenofovir alafenamide, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Macleods Pharmaceuticals

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tenofovir alafenamide, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Micro Labs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Alembic Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Laurus Labs

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 4 active US DMFs for tenofovir alafenamide, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Cipla

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tenofovir alafenamide, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

MSN Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Shilpa Pharma Lifesciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2019. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Chongqing Carelife Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Reyoung Pharmaceuticals

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2022. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2020. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2017. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Arene Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tenofovir alafenamide, filing since 2026. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Matrix Pharmacorp

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2015. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for tenofovir alafenamide, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Aurisco Pharmaceutical Co.,Ltd

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for tenofovir alafenamide, filing since 2020. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Pharbaco

Vietnam
Makes the API

Registered with DAV (Vietnam) for tenofovir alafenamide. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Esteve Química

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for tenofovir alafenamide.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

Gilead Alberta .ULC

Canada
Makes the API

Registered with SFDA (Saudi Arabia) for tenofovir alafenamide.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

21 more manufacturers hold filings for tenofovir alafenamide

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Micro LabsAlembic PharmaceuticalsLaurus LabsCiplaMSN LaboratoriesShilpa Pharma LifesciencesChongqing Carelife PharmaceuticalReyoung PharmaceuticalsApitoria PharmaShanghai Desano Chemical PharmaceuticalArene Life SciencesMatrix PharmacorpShijiazhuang Lonzeal PharmaceuticalsAurisco Pharmaceutical Co.,LtdPharbacoEsteve QuímicaGilead Alberta .ULC
Open the full list with a free account

Finished-dose makers (24)

Gilead Sciences United States Viatris United States Janssen-Cilag Farmaceutica Ltda Brazil Apotex Canada Zentiva, k.s Czech Republic Mylan Pharmaceuticals United States Natco Pharma India Annora Pharma India Bristol-Myers Squibb United States Avantika Medex India Genix Pharma Pakistan Getz Pharma Pakistan LEO Pharma A/S Denmark Patheon Canada Gador S A Argentina "Rv Lifesciences" India Hilton Pharma Pakistan Lotus Pharmaceutical Taiwan Công ty cổ phần S.P.M Vietnam Công Ty TNHH Liên Doanh Stellapharm Vietnam

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

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Also on this molecule

Recalls 1 Finished dose 24 Contract mfrs 0

By country

India 21 China 10

Sold in these combinations

Emtricitabine + Tenofovir Alafenamide 2 APIs

Fixed-dose combinations containing tenofovir alafenamide. Each page leads with the verified API makers of every component.