Molecules / Atorvastatin

Atorvastatin API manufacturers

CAS 134523-00-5 ATC C10AA05 · Statins Updated 9 July 2026
58
manufacturers with an active filing 37 of them hold a US DMF or a CEP
$165.01
median export price per kg $128.89 to $190.00 · 77 exporters · 2025
574
shortage records on file across 15 countries
1,696
finished-dose makers across 54 regulators
Showing 20 of 58 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Hetero

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

Holds one active US DMF and one valid CEP for atorvastatin, filing since 2012. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Biocon

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

Holds one active US DMF and one valid CEP for atorvastatin, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
1 valid
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
06

MSN Life Sciences

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

Holds one active US DMF and one valid CEP for atorvastatin, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
07

Morepen Laboratories

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

Holds one active US DMF and one valid CEP for atorvastatin, filing since 2012. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
08

Laurus Labs

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

Holds 2 active US DMFs and one valid CEP for atorvastatin, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
11

Cadila Pharmaceuticals

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

Holds one active US DMF for atorvastatin, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

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

Torrent Pharmaceuticals

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

Holds one active US DMF for atorvastatin, filing since 2009. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Apotex

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

Holds one active US DMF for atorvastatin, filing since 2008. 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
14

Macleods Pharmaceuticals

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

Holds 2 active US DMFs for atorvastatin, filing since 2010. 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
15

Lek Pharmaceuticals D.D

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

Holds one active US DMF for atorvastatin, filing since 2005. Its GMP is recognised in 13 markets.

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

Amoli Organics

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

Holds one active US DMF for atorvastatin, filing since 2011. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Lupin

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

Holds 2 valid CEPs for atorvastatin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced EDQM certificate database
View profile
19

Raks Pharma

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

Holds one active US DMF for atorvastatin, filing since 2012. Its 2025 FDA inspection closed as NAI.

US DMF
1 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
20

Apitoria Pharma

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

Holds one active US DMF and 2 valid CEPs for atorvastatin, filing since 2010. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

55 more manufacturers hold filings for atorvastatin

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

Synthimed LabsZhejiang Jiangbei PharmaceuticalMSN Life SciencesMorepen LaboratoriesLaurus LabsMankind PharmaZydus LifesciencesCadila PharmaceuticalsTorrent PharmaceuticalsApotexMacleods PharmaceuticalsLek Pharmaceuticals D.DZhejiang Haisen PharmaceuticalAmoli OrganicsLupinRaks PharmaApitoria Pharma
Open the full list with a free account

Contract manufacturers (14)

Dr. Reddy's Laboratories India Torrent Pharmaceuticals India Morepen Laboratories India S Kant Healthcare India Rafarm Greece Zhejiang Haizhou Pharmaceutical China Flamingo Pharmaceuticals India Hanmi Fine Chemical South Korea Kopran India Titan Laboratories India Lgm Pharma United States Amoli Organics Umedica Laboratories India Grupo Azevedos Portugal Simson Pharma India

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

Finished-dose makers (134)

Viatris United States Pfizer Brasil Ltda Brazil Zentiva, k.s Czech Republic Sandoz Switzerland Alembic Pharmaceuticals India Pharmascience Canada Ajanta Pharma India MSN Laboratories India Lek Poland Olpha Latvia Teva Israel Egis Pharmaceuticals Hungary Eurofarma Laboratorios Brazil Amneal United States CMP Pharma United States Msd International Gmbh (Puerto Rico Branch) United States Novartis Switzerland Micro Labs India Ferrer Internacional Spain Les Laboratoires Servier Industrie France

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 574 Recalls 26 Finished dose 134 Contract mfrs 14

By country

India 29

Export price by year

Year Median Exporters
2025 $165.01 77
2024 $188.08 84
2023 $200.65 89
2022 $208.87 74

US dollars per kilogram, customs export unit values.