Molecules / Spiramycin

Spiramycin API manufacturers

CAS 8025-81-8 ATC J01FA02 · Macrolide antibiotics Updated 9 July 2026
16
manufacturers with an active filing 2 of them hold a US DMF or a CEP
5
shortage records on file across 1 countries
182
finished-dose makers across 30 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Euroapi France

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

Holds one valid CEP for spiramycin, filing since 2025. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2021 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
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02

Topfond Pharmaceutical

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

Holds one valid CEP for spiramycin, filing since 2021.

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
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03

Công ty Cổ phần Nam Dược

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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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04

Công ty cổ phần dược phẩm Boston Việt Nam

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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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05

Công ty Cổ phần Dược phẩm Gia Nguyễn

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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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06

Registered with DAV (Vietnam) for spiramycin. 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

Công ty TNHH BRV Healthcare

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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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08

SaVipharm J.S.C

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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
09

Công ty: CP US Pharma USA

Vietnam
Makes the API

Registered with DAV (Vietnam) for spiramycin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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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11

Công Ty Cp Xnk Y Tế Domesco

Vietnam
Makes the API

Registered with DAV (Vietnam) for spiramycin. 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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Registered with DAV (Vietnam) for spiramycin. 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
13

Công ty TNHH MTV 120 Armephaco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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
14

Mediplantex

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for spiramycin. 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

Registered with DAV (Vietnam) for spiramycin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Cty Tnhh Dược Phẩm Usa-Nic

Vietnam
Makes the API

Registered with DAV (Vietnam) for spiramycin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

Contract manufacturers (3)

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

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Sold in these combinations

Fixed-dose combinations containing spiramycin. Each page leads with the verified API makers of every component.