Molecules / Mycophenolic Acid

Mycophenolic Acid API manufacturers

CAS 24280-93-1 ATC L04AA06 Updated 9 July 2026
17
manufacturers with an active filing 17 of them hold a US DMF or a CEP
$212.20
median export price per kg $168.00 to $419.92 · 11 exporters · 2025
12
shortage records on file across 1 countries
187
finished-dose makers across 37 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Biocon

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

Registered with SFDA (Saudi Arabia) for mycophenolic acid. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Concord Biotech

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

Registered with SFDA (Saudi Arabia) for mycophenolic acid. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

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

Teva

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

Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Apotex

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

Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
None on file
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
06

Novartis

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

Holds one active US DMF for mycophenolic acid, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 35 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
35 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Excella Gmbh

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

Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
None on file
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
09

Wuxi Fortune Pharmaceutical

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

Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Formosa Laboratories

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

Holds 2 active US DMFs for mycophenolic acid, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Dasami Lab

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

Its 2025 FDA inspection closed as VAI.

US DMF
None on file
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

Chongqing Daxin Pharmaceutical

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

Holds 2 active US DMFs for mycophenolic acid, filing since 2007. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Kiyan Pharma

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

Holds one active US DMF for mycophenolic acid, filing since 2000. Its 2016 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2016 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Lunan New Time Bio-Tech

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

Holds one active US DMF for mycophenolic acid, filing since 2011.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
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 mycophenolic acid, filing since 2017. 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
17

Curia

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

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

14 more manufacturers hold filings for mycophenolic acid

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

Solara Active Pharma SciencesApotexNovartisExcella GmbhRakshit PharmaceuticalsWuxi Fortune PharmaceuticalFormosa LaboratoriesChunghwa Chemical Synthesis & BiotechDasami LabChongqing Daxin PharmaceuticalKiyan PharmaLunan New Time Bio-TechLivzon Group Ningxia PharmaceuticalCuria
Open the full list with a free account

Finished-dose makers (15)

Joyang Laboratories China Novartis Pharma Produktions Germany Hetero India Sandoz Switzerland Strides Pharma Science India Delpharm Milano Italy Jamp Pharma Canada Alkem Laboratories India Novartis Farmacéutica, S. A Spain "West-Coast Pharmaceutical Works India Lek Pharmaceuticals D.D Slovenia Aurobindo Pharma India Viatris United States Laboratorio Stada S.L Spain Panacea Biotec Pharma 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.

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Also on this molecule

Price history 4 yrs Shortages 12 Recalls 2 Finished dose 15 Contract mfrs 0

Export price by year

Year Median Exporters
2025 $212.20 11
2024 $205.00 11
2023 $189.00 9
2022 $198.75 9

US dollars per kilogram, customs export unit values.