Molecules / Rosuvastatin

Rosuvastatin API manufacturers

CAS 287714-41-4 ATC C10AA07 · Statins Updated 9 July 2026
60
manufacturers with an active filing 44 of them hold a US DMF or a CEP
$445.50
median export price per kg $275.26 to $624.00 · 80 exporters · 2025
453
shortage records on file across 14 countries
1,595
finished-dose makers across 53 regulators
Showing 20 of 60 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

Holds 3 active US DMFs and 3 valid CEPs for rosuvastatin, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
3 active
CEP
3 valid
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
EDQM certificate database
View profile
04

Lee Pharma

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

Holds one active US DMF and one valid CEP for rosuvastatin, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
06

Mankind Pharma

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 rosuvastatin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
07

MSN Life Sciences

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 rosuvastatin, filing since 2020. 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
13

Hetero

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

Holds 2 active US DMFs for rosuvastatin, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Lupin

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

Holds one active US DMF for rosuvastatin, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

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

Nosch Labs

India
Makes the API

Holds one valid CEP for rosuvastatin, filing since 2025. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced EDQM certificate database
View profile
16

Amoli Organics

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

Holds 2 active US DMFs for rosuvastatin, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
2 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
17

Lek Pharmaceuticals D.D

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

Holds 2 active US DMFs for rosuvastatin, filing since 2007. Its GMP is recognised in 13 markets.

US DMF
2 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
18

Zydus Lifesciences

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

Holds one active US DMF for rosuvastatin, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Ruyuan Hec Pharm

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

Holds 2 active US DMFs for rosuvastatin, filing since 2015. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for rosuvastatin. 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

57 more manufacturers hold filings for rosuvastatin

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

Lee PharmaMorepen LaboratoriesMankind PharmaMSN Life SciencesAlivus Life SciencesShaoxing Jingxin PharmaceuticalCTX LifesciencesInnovare LabsMelody HealthcareHeteroLupinNosch LabsAmoli OrganicsLek Pharmaceuticals D.DZydus LifesciencesRuyuan Hec PharmGlenmark Pharmaceuticals s.r.o
Open the full list with a free account

Contract manufacturers (14)

Torrent Pharmaceuticals India Morepen Laboratories India CTX Lifesciences India Zhejiang Jiangbei Pharmaceutical China Corona Remedies India Finecure pharmaceuticals India Rafarm Greece Zhejiang Haizhou Pharmaceutical China Titan Laboratories India Hunan Jiudian Hongyang Pharmaceutical China Amoli Organics Umedica Laboratories India Grupo Azevedos Portugal Pharmazac Greece Surya Life Sciences India

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

Finished-dose makers (131)

Cadila Pharmaceuticals India Astrazeneca Pharmaceuticals Lp United States Zentiva, k.s Czech Republic Sanofi France Cipla India Pharmascience Canada Shandong New Time Pharmaceutical China Sandoz Switzerland Apotex Canada Egis Pharmaceuticals Hungary Viatris United States Micro Labs India Torrent Pharmaceuticals India Ajanta Pharma India Amneal United States Lek Poland Marksans Pharma India Olpha Latvia Teva Israel AstraZeneca UK United Kingdom

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 453 Recalls 19 Finished dose 131 Contract mfrs 14

By country

India 29

Export price by year

Year Median Exporters
2025 $445.50 80
2024 $474.31 92
2023 $575.00 115
2022 $702.80 81

US dollars per kilogram, customs export unit values.