Molecules / Efavirenz

Efavirenz API manufacturers

CAS 154598-52-4 ATC J05AG03 Updated 9 July 2026
12
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$112.02
median export price per kg $100.00 to $376.50 · 7 exporters · 2025
48
shortage records on file across 11 countries
387
finished-dose makers across 48 regulators
Showing 12 of 12 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 4 active US DMFs for efavirenz, filing since 2006. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
4 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

Laurus Labs

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

Holds 4 active US DMFs for efavirenz, filing since 2008. 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
03

Macleods Pharmaceuticals

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

Holds one active US DMF for efavirenz, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 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

Cipla

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

Holds one active US DMF for efavirenz, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 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
05

Apitoria Pharma

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

Holds 2 active US DMFs for efavirenz, filing since 2004. Its 2025 FDA inspection closed as VAI.

US DMF
2 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
06
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for efavirenz, filing since 2009. 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
07

Arene Life Sciences

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

Holds 2 active US DMFs for efavirenz, filing since 2019. 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
08

Matrix Pharmacorp

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

Holds 3 active US DMFs for efavirenz, filing since 2005. Its 2025 FDA inspection closed as VAI.

US DMF
3 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
09

Cdymax (India) Pharma

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

Holds one active US DMF for efavirenz, filing since 2011. Its GMP is recognised in 1 market.

US DMF
1 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
10

SMS Pharmaceuticals

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

Holds one active US DMF for efavirenz, filing since 2021. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

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

Zhejiang Huahai Pharmaceutical

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

Holds one active US DMF for efavirenz, filing since 2016. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Pharbaco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for efavirenz. 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

9 more manufacturers hold filings for efavirenz

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

CiplaApitoria PharmaShanghai Desano Chemical PharmaceuticalArene Life SciencesMatrix PharmacorpCdymax (India) PharmaSMS PharmaceuticalsZhejiang Huahai PharmaceuticalPharbaco
Open the full list with a free account

Contract manufacturers (2)

Arene Life Sciences India Anhui Biochem Pharmaceutical China

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (52)

Viatris United States Bristol-Myers Squibb United States Zentiva, k.s Czech Republic Mylan Pharmaceuticals United States Apotex Canada Dr. Reddy's Laboratories India Glenmark Pharmaceuticals s.r.o Czech Republic Teva Israel Aurobindo Pharma India Micro Labs India Sandoz Switzerland Gilead Sciences United States Adcock Ingram South Africa Jamp Pharma Canada Merck Sharp & Dohme Farmaceutica Ltda., Brasil Brazil STADA Arzneimittel Germany Merck Sharp & Dohme United States Bristol Myers Squibb Manufacturing United States Patheon Canada Novagen Healthcare Pvt.Ltd India

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
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

Map efavirenz for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Price history 3 yrs Shortages 48 Recalls 4 Finished dose 52 Contract mfrs 2

By country

India 15

Sold in these combinations

Emtricitabine + Tenofovir Disoproxil + Efavirenz 3 APIs

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

Export price by year

Year Median Exporters
2025 $112.02 7
2023 $171.00 5
2022 $125.00 5

US dollars per kilogram, customs export unit values.