Molecules / Ambroxol / India

Ambroxol API manufacturers in India

CAS 18683-91-5 ATC R05CB06 Updated 9 July 2026
6
India-based manufacturers with an active filing of 19 worldwide
$61.50
median export price per kg, all origins $39.71 to $166.78 · 25 exporters · 2025
Showing 4 of 6 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Shilpa Pharma Lifesciences

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

Holds one valid CEP for ambroxol, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Ami Lifesciences

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

Holds 2 valid CEPs for ambroxol, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
View profile
03

Kores India

India
Makes the API

Holds one valid CEP for ambroxol, 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
04

Shivalik Rasayan

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

Holds one valid CEP for ambroxol, 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

2 more manufacturers in India hold filings for ambroxol

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

Kores IndiaShivalik Rasayan
Open the full list with a free account

How this list is built

This page filters the worldwide Ambroxol manufacturer list to companies based in India. 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. Read the full method.

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All Ambroxol manufacturers

Worldwide 19