Molecules / Icatibant

Icatibant API manufacturers

CAS 130308-48-4 ATC B06AC02 Updated 9 July 2026
14
manufacturers with an active filing 14 of them hold a US DMF or a CEP
13
shortage records on file across 5 countries
225
finished-dose makers across 25 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for icatibant, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

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

Fresenius Kabi Ab

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

Holds one active US DMF for icatibant, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

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

Alembic Pharmaceuticals

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

Holds one active US DMF for icatibant, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

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

USV

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

Holds one active US DMF for icatibant, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Cipla

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

Holds one active US DMF for icatibant, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
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
06

MSN Laboratories

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

Holds one active US DMF for icatibant, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Bachem

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

Holds one active US DMF for icatibant, filing since 2007. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Biophore India Pharmaceuticals

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

Holds one active US DMF for icatibant, filing since 2016. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Bcn Peptides

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

Holds 2 active US DMFs for icatibant, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Auro Peptides

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

Holds one active US DMF for icatibant, filing since 2019. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for icatibant, filing since 2016. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Chengdu Shengnuo Biopharm

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

Holds one active US DMF for icatibant, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Matrix Pharmacorp

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

Holds one active US DMF for icatibant, filing since 2016. Its 2025 FDA inspection closed as VAI.

US DMF
1 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
14

Ambio

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

Holds one active US DMF for icatibant, filing since 2015. Its GMP is recognised in 1 market.

US DMF
1 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

11 more manufacturers hold filings for icatibant

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

USVCiplaMSN LaboratoriesBachemBiophore India PharmaceuticalsBcn PeptidesAuro PeptidesJiangsu Hansoh Pharmaceutical GroupChengdu Shengnuo BiopharmMatrix PharmacorpAmbio
Open the full list with a free account

Contract manufacturers (6)

Biophore India Pharmaceuticals India Bachem Switzerland Zhejiang Peptites Biotech China Gp Pharm Spain Centurion Pharma Turkey Onko İlaç Sanayi̇ Veti̇caret A.Ş Turkey

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

Finished-dose makers (20)

HIKMA ITALIA Italy Teva Israel Glenmark Pharmaceuticals s.r.o Czech Republic Zentiva, k.s Czech Republic Viatris United States Gp Pharm Spain Piramal Pharma United States Universal Farma, S.L Spain Ethypharm France Jiangsu Hengrui Pharmaceuticals China Juno Pharmaceuticals Canada Lupin India MSN Laboratories India Sandoz Switzerland STADA Arzneimittel Germany Takeda Pharma Ltda Brazil Genus Pharmaceuticals United Kingdom Eg S P A Italy Laboratorio Stada S.L Spain Centurion 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

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Also on this molecule

Shortages 13 Finished dose 20 Contract mfrs 6

By country

India 14