Molecules / Sertraline

Sertraline API manufacturers

CAS 79617-96-2 ATC N06AB06 · SSRI antidepressants Updated 9 July 2026
24
manufacturers with an active filing 19 of them hold a US DMF or a CEP
$125.24
median export price per kg $108.00 to $158.37 · 54 exporters · 2025
225
shortage records on file across 8 countries
859
finished-dose makers across 50 regulators
Showing 20 of 24 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

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 sertraline, filing since 2023. 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
02

Lupin

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

Holds one active US DMF and 2 valid CEPs for sertraline, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
03

Hetero

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

Holds 4 active US DMFs for sertraline, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
4 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
04

Symed Labs

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

Holds 2 active US DMFs and one valid CEP for sertraline, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
05

Dr. Reddy's Laboratories

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

Holds one active US DMF for sertraline, filing since 2002. 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
06

Torrent Pharmaceuticals

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

Holds one active US DMF for sertraline, filing since 2005. 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
08

Exemed Pharmaceuticals

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

Holds 2 active US DMFs for sertraline, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Nosch Labs

India
Makes the API

Holds one valid CEP for sertraline, filing since 2024. 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
10

Amoli Organics

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

Holds one active US DMF for sertraline, filing since 2021. 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
11

Natco Pharma

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

Holds one valid CEP for sertraline, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
View profile
12

Apitoria Pharma

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

Holds 2 active US DMFs and one valid CEP for sertraline, filing since 2004. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Wanbury

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

Holds 2 active US DMFs for sertraline, filing since 2005. Its 2024 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Chemeca Drugs

India
Makes the API

Holds one active US DMF for sertraline, filing since 2019. Its 2023 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

R.L.Fine Chem

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

Holds one active US DMF for sertraline, filing since 2024. 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
16

Matrix Pharmacorp

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

Holds 2 active US DMFs for sertraline, filing since 2004. Its 2025 FDA inspection closed as VAI.

US DMF
2 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
17

Moehs

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

Holds one valid CEP for sertraline, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
18

Verdant Life Sciences

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

Holds one valid CEP for sertraline, filing since 2025.

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
View profile
19

Công ty TNHH Liên Doanh Stellapharm - Chi nhánh 1

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for sertraline. 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
20

Ampharco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for sertraline. 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

Contract manufacturers (1)

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

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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By country

Export price by year

Year Median Exporters
2025 $125.24 54
2024 $125.00 63
2023 $128.75 74
2022 $132.45 57

US dollars per kilogram, customs export unit values.