Molecules / Scopolamine

Scopolamine API manufacturers

CAS 51-34-3 ATC A04AD01 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$1207.32
median export price per kg $1122.35 to $1350.00 · 67 exporters · 2025
22
shortage records on file across 2 countries
109
finished-dose makers across 18 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Fine Chemicals Corporation (PTY)

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

Holds one active US DMF for scopolamine, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 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
02

Alchem International

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

Holds 2 active US DMFs for scopolamine, filing since 2016. 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
03

Alkaloids

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

Holds 2 active US DMFs for scopolamine, filing since 2015. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Phytex Australia

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

Holds one active US DMF for scopolamine, filing since 1988.

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
05

Phytex Australia Pty

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

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile

2 more manufacturers hold filings for scopolamine

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

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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
2026 YTD $1222.20 27
2025 $1207.32 67
2024 $1156.23 51
2023 $1182.27 54

US dollars per kilogram, customs export unit values.