Molecules / Naphazoline

Naphazoline API manufacturers

CAS 835-31-4 ATC R01AA08 Updated 9 July 2026
7
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$700.00
median export price per kg $552.17 to $805.00 · 9 exporters · 2025
1
shortage records on file across 1 countries
330
finished-dose makers across 39 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Micro Labs

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

Holds one active US DMF and 2 valid CEPs for naphazoline, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

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

Biophore India Pharmaceuticals

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

Holds 2 active US DMFs for naphazoline, filing since 2021. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Precise Biopharma

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

Holds one valid CEP for naphazoline, filing since 2026. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
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05

Rank Organics Chemical

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

Holds one active US DMF for naphazoline, filing since 2018.

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
06

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for naphazoline. 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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07

Minh

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for naphazoline. 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

4 more manufacturers hold filings for naphazoline

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 $700.00 9
2024 $650.00 17
2023 $568.85 9
2022 $607.07 15

US dollars per kilogram, customs export unit values.