Synopsis
0
CEP/COS
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
Click Us!
KDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-14
Pay. Date : 2022-12-16
DMF Number : 37455
Submission : 2022-09-16
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-29
Pay. Date : 2019-10-03
DMF Number : 34170
Submission : 2019-10-03
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-23
Pay. Date : 2019-03-28
DMF Number : 32614
Submission : 2018-06-27
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33747
Submission : 2019-07-24
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-26
Pay. Date : 2019-06-10
DMF Number : 33924
Submission : 2019-06-29
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-01
Pay. Date : 2019-07-15
DMF Number : 33864
Submission : 2019-07-18
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-09
DMF Number : 34113
Submission : 2019-10-01
Status :
Type : II
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40158
Submission : 2024-07-24
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Suanfarma, at the Core of a Better Life.
CAS Number : 173094-60-5
End Use API : Sugammadex Sodium
About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
Suanfarma, at the Core of a Better Life.
CAS Number : 53784-84-2
End Use API : Sugammadex Sodium
About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
USFDA APPLICATION NUMBER - 22225
DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
USFDA APPLICATION NUMBER - 22225
Related Excipient Companies
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
APIs
Reply
23 Mar 2026
Reply
26 Aug 2025
Reply
01 Aug 2025
Reply
10 Jun 2025
Reply
18 Sep 2023
Reply
05 Sep 2023
Reply
19 Jan 2022
Reply
18 Jan 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
64
PharmaCompass offers a list of Sugammadex Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sugammadex Sodium manufacturer or Sugammadex Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sugammadex Sodium manufacturer or Sugammadex Sodium supplier.
A Sugammadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sugammadex, including repackagers and relabelers. The FDA regulates Sugammadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sugammadex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Sugammadex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sugammadex supplier is an individual or a company that provides Sugammadex active pharmaceutical ingredient (API) or Sugammadex finished formulations upon request. The Sugammadex suppliers may include Sugammadex API manufacturers, exporters, distributors and traders.
click here to find a list of Sugammadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sugammadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Sugammadex active pharmaceutical ingredient (API) in detail. Different forms of Sugammadex DMFs exist exist since differing nations have different regulations, such as Sugammadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sugammadex DMF submitted to regulatory agencies in the US is known as a USDMF. Sugammadex USDMF includes data on Sugammadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sugammadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sugammadex suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Sugammadex Drug Master File in Japan (Sugammadex JDMF) empowers Sugammadex API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Sugammadex JDMF during the approval evaluation for pharmaceutical products. At the time of Sugammadex JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Sugammadex suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sugammadex Drug Master File in Korea (Sugammadex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sugammadex. The MFDS reviews the Sugammadex KDMF as part of the drug registration process and uses the information provided in the Sugammadex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sugammadex KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sugammadex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sugammadex suppliers with KDMF on PharmaCompass.
A Sugammadex written confirmation (Sugammadex WC) is an official document issued by a regulatory agency to a Sugammadex manufacturer, verifying that the manufacturing facility of a Sugammadex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sugammadex APIs or Sugammadex finished pharmaceutical products to another nation, regulatory agencies frequently require a Sugammadex WC (written confirmation) as part of the regulatory process.
click here to find a list of Sugammadex suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sugammadex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sugammadex API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Sugammadex as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Sugammadex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sugammadex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sugammadex suppliers with NDC on PharmaCompass.
Sugammadex Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Sugammadex GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sugammadex GMP manufacturer or Sugammadex GMP API supplier for your needs.
A Sugammadex CoA (Certificate of Analysis) is a formal document that attests to Sugammadex's compliance with Sugammadex specifications and serves as a tool for batch-level quality control.
Sugammadex CoA mostly includes findings from lab analyses of a specific batch. For each Sugammadex CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Sugammadex may be tested according to a variety of international standards, such as European Pharmacopoeia (Sugammadex EP), Sugammadex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sugammadex USP).
Comment (6)
