Molecules / Glycopyrronium

Glycopyrronium API manufacturers

CAS 740028-90-4 ATC A03AB02 Updated 9 July 2026
23
manufacturers with an active filing 22 of them hold a US DMF or a CEP
$25020.50
median export price per kg $13351.69 to $60955.39 · 9 exporters · 2025
8
shortage records on file across 2 countries
294
finished-dose makers across 41 regulators
Showing 20 of 23 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Harman Finochem

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

Holds one valid CEP for glycopyrronium, filing since 2006. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

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

HIKMA ITALIA

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

Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 14 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Melody Healthcare

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

Holds one valid CEP for glycopyrronium, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Olon

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

Holds one active US DMF and one valid CEP for glycopyrronium, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

FDC

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

Holds 3 valid CEPs for glycopyrronium, filing since 2025. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
None on file
CEP
3 valid
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
How this listing is sourced EDQM certificate database
View profile
06

AMSA

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

Holds one valid CEP for glycopyrronium, filing since 2003. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
07

Cipla

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

Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Hainan Poly Pharm

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

Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Cohance Lifesciences

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

Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Shilpa Pharma Lifesciences

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

Holds one valid CEP for glycopyrronium, filing since 2023. 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
11

Swati Spentose

India
Makes the API

Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
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
12

Resonance Laboratories

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

Its 2025 FDA inspection closed as VAI.

US DMF
None on file
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
13

Viyash Life Sciences

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

Its 2025 FDA inspection closed as VAI.

US DMF
None on file
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
14

Pcas

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

Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Suven Pharmaceuticals

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

Holds 2 active US DMFs for glycopyrronium, filing since 2019. Its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Inke

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

Its 2023 FDA inspection closed as VAI.

US DMF
None on file
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
18

Vamsi Labs

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

Holds one valid CEP for glycopyrronium, filing since 2026. Its 2018 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile

20 more manufacturers hold filings for glycopyrronium

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

OlonFDCAMSACiplaHainan Poly PharmCohance LifesciencesShilpa Pharma LifesciencesSwati SpentoseResonance LaboratoriesViyash Life SciencesPcasSuven PharmaceuticalsInkeNishchem InternationalVamsi LabsAkshat PharmaBreathgreen Pharmaceutical
Open the full list with a free account

Contract manufacturers (3)

Hovione Farmaciência Portugal Consulatam Unipessoal Lda Tooba Pharmaceuticals India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (59)

Amneal United States Astrazeneca Pharmaceuticals Lp United States Dr. Reddy's Laboratories India Fresenius Kabi Ab Sweden Glenmark Pharmaceuticals s.r.o Czech Republic Ajenat Pharmaceuticals United States Alembic Pharmaceuticals India Gland Pharma India Granules India India Nivagen Pharmaceuticals United States Saptalis Pharmaceuticals United States American Regent United States Hospira United States Merz Pharmaceuticals Germany Sintetica Switzerland Teva Israel Viatris United States Zentiva, k.s Czech Republic Chiesi Farmaceutici Italy Flagship Biotech International India

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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Also on this molecule

Price history 3 yrs Shortages 8 Finished dose 59 Contract mfrs 3

By country

India 24 Italy 5

Sold in these combinations

Beclomethasone Dipropionate + Glycopyrronium + Formoterol 3 APIs Budesonide + Glycopyrronium + Formoterol 3 APIs

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

Export price by year

Year Median Exporters
2025 $25020.50 9
2024 $32000.00 10
2023 $29700.21 10

US dollars per kilogram, customs export unit values.