Molecules / Adapalene

Adapalene API manufacturers

CAS 106685-40-9 ATC D10AD03 · Topical retinoids Updated 9 July 2026
16
manufacturers with an active filing 10 of them hold a US DMF or a CEP
$4037.71
median export price per kg $2492.46 to $6888.23 · 20 exporters · 2025
17
shortage records on file across 3 countries
356
finished-dose makers across 51 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Alivus Life Sciences

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

Holds 2 active US DMFs and one valid CEP for adapalene, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
02

Maithri Drugs

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

Holds one active US DMF and one valid CEP for adapalene, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
03

Olon

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

Holds one active US DMF and one valid CEP for adapalene, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
04

Alembic Pharmaceuticals

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

Holds one active US DMF for adapalene, filing since 2026. 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
05

Excella Gmbh

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

Holds one active US DMF for adapalene, filing since 2006. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for adapalene. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
07

Medichem

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

Holds one active US DMF for adapalene, filing since 2008. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Bal Pharma

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

Holds one valid CEP for adapalene, filing since 2023. Its GMP is recognised in 11 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
11 markets
How this listing is sourced EDQM certificate database
View profile
09

Finorga

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

Holds one active US DMF for adapalene, filing since 1990. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

HAS Healthcare Advanced Synthesis

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

Holds 2 active US DMFs for adapalene, filing since 2005. Its 2025 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Aarti Pharmalabs

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

Holds one active US DMF for adapalene, filing since 2009. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Aartiindustrieslimited

India
Makes the API

Registered with PMDA (Japan) for adapalene.

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
13

Ampharco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for adapalene. 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
14

BalPharmaLimited

India
Makes the API

Registered with PMDA (Japan) for adapalene.

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
15

Helsinn Advanced Synthesis

Switzerland
Makes the API

Registered with SFDA (Saudi Arabia) for adapalene.

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
16

Công ty cổ phần dược phẩm Boston Việt Nam

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for adapalene. 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

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.

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By country

Export price by year

Year Median Exporters
2026 YTD $4232.80 13
2025 $4037.71 20
2024 $4063.19 24
2023 $3561.17 22

US dollars per kilogram, customs export unit values.