Molecules / Eszopiclone

Eszopiclone API manufacturers

CAS 138729-47-2 ATC N05CF04 Updated 9 July 2026
13
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$2978.85
median export price per kg $2724.53 to $6438.73 · 12 exporters · 2025
136
finished-dose makers across 24 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for eszopiclone, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Centaur Pharmaceuticals

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

Registered with SFDA (Saudi Arabia) for eszopiclone. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

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

Lupin

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

Holds one active US DMF for eszopiclone, filing since 2008. 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
04

Macleods Pharmaceuticals

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

Holds one active US DMF for eszopiclone, filing since 2010. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 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
05

Alivus Life Sciences

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

Holds 2 active US DMFs for eszopiclone, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Symed Labs

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

Holds 2 active US DMFs for eszopiclone, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Orbion Pharmaceuticals

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

Holds one active US DMF for eszopiclone, filing since 2008.

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
08

R.L.Fine Chem

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Matrix Pharmacorp

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

Holds one active US DMF for eszopiclone, filing since 2008. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
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
11
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eszopiclone, filing since 2023. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

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

Registered with DAV (Vietnam) for eszopiclone. 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
13

Công ty cổ phần dược phẩm SaVi

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for eszopiclone. 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

10 more manufacturers hold filings for eszopiclone

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

Macleods PharmaceuticalsAlivus Life SciencesSymed LabsOrbion PharmaceuticalsR.L.Fine ChemMatrix PharmacorpTianjin Tasly Sants PharmaceuticalCalyx Chemicals and PharmaceuticalsCông ty Cổ phần Dược phẩm Khánh Hòa (Khapharco)Công ty cổ phần dược phẩm SaVi
Open the full list with a free account

Finished-dose makers (24)

Hetero India Sumitomo Pharma Japan HIKMA ITALIA Italy Eurofarma Laboratorios Brazil Ipca Laboratories India Pfizer Brasil Ltda Brazil Aché Laboratorios Farmacéuticos S. A Brazil Gador S A Argentina Laboratorio Elea Phoenix Argentina Laboratorios Andrómaco Chile Acromax Laboratorio Quimico Farmaceutico S A Ecuador C.I. Farmacapsulas Colombia Laboratorios Saval Chile Siegfried Colombia Laboratorios Synthesis, S.A.S Colombia Roemmers Argentina Alfacure Pharmaceutical Egypt Chartwell RX United States Công Ty TNHH Dược Phẩm Hạnh Thái Vietnam Công ty cổ phần S.P.M 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 4 yrs Recalls 3 Finished dose 24 Contract mfrs 0

By country

India 17

Export price by year

Year Median Exporters
2025 $2978.85 12
2024 $3090.30 7
2023 $3104.12 7
2022 $3341.46 5

US dollars per kilogram, customs export unit values.