Molecules / Guanfacine

Guanfacine API manufacturers

CAS 29110-47-2 ATC C02AC02 Updated 9 July 2026
9
manufacturers with an active filing 7 of them hold a US DMF or a CEP
21
shortage records on file across 2 countries
58
finished-dose makers across 17 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Torrent Pharmaceuticals

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

Holds one active US DMF for guanfacine, filing since 2014. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Medichem

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

Holds one active US DMF for guanfacine, filing since 1990. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Quimica Sintetica

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

Holds one active US DMF for guanfacine, filing since 1990. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for guanfacine, filing since 2014. Its 2022 FDA inspection closed as VAI.

US DMF
2 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
07

PROCOS

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

Holds one active US DMF for guanfacine, filing since 2014. 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
08

PharmaZell

Germany
Makes the API

Registered with SFDA (Saudi Arabia) for guanfacine. Its 2022 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
09

Chemo Química Sintética

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for guanfacine.

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

6 more manufacturers hold filings for guanfacine

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 (1)

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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