Molecules / Fluvastatin

Fluvastatin API manufacturers

CAS 93957-54-1 ATC C10AA04 · Statins Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$811.41
median export price per kg $745.00 to $1022.86 · 6 exporters · 2025
27
shortage records on file across 7 countries
159
finished-dose makers across 24 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Novartis

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

Holds one active US DMF for fluvastatin, filing since 2010. 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
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03
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for fluvastatin, filing since 2005. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Pharmathen Industrial

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

Holds one active US DMF for fluvastatin, filing since 2010.

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
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05

Apitoria Pharma

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

Holds one valid CEP for fluvastatin, filing since 2024.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
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06

Registered with DAV (Vietnam) for fluvastatin. 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
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3 more manufacturers hold filings for fluvastatin

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

Pharmathen IndustrialApitoria PharmaCông ty cổ phần dược phẩm SaVi
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Finished-dose makers (20)

Viatris United States Teva Israel Sandoz Switzerland Zentiva, k.s Czech Republic Lannett United States Laboratorios Cinfa S A Spain Laboratorios Normon Spain Pharmathen Greece Laboratorios Alter Spain Aristo Pharma Germany Laboratórios Atral Portugal Công ty cổ phần Dược và Vật tư y tế Bình Thuận Vietnam Eg S P A Italy Laboratorio Stada S.L Spain Nhà máy HDPHARMA EU - Công ty cổ phần Dược Vật tư y tế Hải Dương Vietnam 'Công ty cổ phần dược phẩm ME DI SUN Vietnam Công ty cổ phần Dược phẩm An Thiên Vietnam Mekophar Chemical Pharmaceutical Vietnam SaVipharm J.S.C Vietnam Wealphar Pharmaceutical Joint Stock 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
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 3 yrs Shortages 27 Finished dose 20 Contract mfrs 0

Export price by year

Year Median Exporters
2025 $811.41 6
2024 $750.00 6
2022 $821.85 5

US dollars per kilogram, customs export unit values.