Molecules / Nortriptyline

Nortriptyline API manufacturers

CAS 72-69-5 ATC N06AA10 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
$132.70
median export price per kg $85.00 to $150.00 · 8 exporters · 2025
22
shortage records on file across 2 countries
104
finished-dose makers across 18 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Centaur Pharmaceuticals

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

Holds one valid CEP for nortriptyline, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced EDQM certificate database
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02

Vasudha Pharma Chem

India
Makes the API

Holds 2 active US DMFs for nortriptyline, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Dipharma Francis

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

Holds one active US DMF for nortriptyline, filing since 1988. 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
View profile
04

Olon

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

Holds one valid CEP for nortriptyline, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
05

Sigma-Aldrich Ireland

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

Holds one active US DMF for nortriptyline, filing since 1988. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

R.L. Fine Chem

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

Holds one active US DMF for nortriptyline, filing since 2018. Its GMP is recognised in 1 market.

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

3 more manufacturers hold filings for nortriptyline

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

Open the full list with a free account

Contract manufacturers (2)

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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Export price by year

Year Median Exporters
2025 $132.70 8
2024 $93.00 13
2023 $98.74 11
2022 $106.46 12

US dollars per kilogram, customs export unit values.