Molecules / Sugammadex

Sugammadex API manufacturers

CAS 343306-71-8 Updated 9 July 2026
35
manufacturers with an active filing 26 of them hold a US DMF or a CEP
$8038.82
median export price per kg $7345.79 to $9359.77 · 11 exporters · 2025
33
shortage records on file across 6 countries
601
finished-dose makers across 42 regulators
Showing 20 of 35 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for sugammadex, filing since 2018. 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

MSN Laboratories

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

Holds one active US DMF for sugammadex, filing since 2019. 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
03

Natco Pharma

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

Holds 2 active US DMFs for sugammadex, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

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

Gland Pharma

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

Holds one active US DMF for sugammadex, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Mankind Pharma

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

Holds 2 active US DMFs for sugammadex, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

USV

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

Holds one active US DMF for sugammadex, filing since 2019. 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
07

Lek Pharmaceuticals D.D

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

Holds one active US DMF for sugammadex, filing since 2019. Its GMP is recognised in 13 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Synthon

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

Holds one active US DMF for sugammadex, filing since 2019. Its GMP is recognised in 14 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

ASolution Pharmaceutical

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

Holds one active US DMF for sugammadex, filing since 2022. Its 2026 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

HEC Pharm

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

Holds one active US DMF for sugammadex, filing since 2019. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Fresenius Kabi Ab

Sweden
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for sugammadex. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
12

Wavelength Enterprises

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

Holds 4 active US DMFs for sugammadex, filing since 2020. Its 2022 FDA inspection closed as NAI.

US DMF
4 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Biophore India Pharmaceuticals

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

Holds one active US DMF for sugammadex, filing since 2019. 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
14

Farmhispania

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

Holds one active US DMF for sugammadex, filing since 2020. 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
15

Honour Lab

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

Holds one active US DMF for sugammadex, filing since 2019. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Solara Active Pharma Sciences

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

Holds one active US DMF for sugammadex, filing since 2019. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Apitoria Pharma

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

Holds one active US DMF for sugammadex, filing since 2019. 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
18

Changzhou Pharmaceutical Factory

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

Holds 3 active US DMFs for sugammadex, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 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
19

Neuland Laboratories

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

Holds 2 active US DMFs for sugammadex, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 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

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
2025 $8038.82 11
2024 $9873.12 14
2023 $13000.00 18
2022 $18717.74 7

US dollars per kilogram, customs export unit values.