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CEP/COS
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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EU-WC
NDC
KDMF
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
EU-WC
KDMF
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
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™
KDMF
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
KDMF
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
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
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
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
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-04
Pay. Date : 2020-10-28
DMF Number : 35319
Submission : 2020-10-29
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
Sichuan Qingmu Pharmaceutical offers reliable CDMO support and high-quality APIs for regulated markets.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40158
Submission : 2024-07-24
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Sugammadex Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Acquired Approval for Manufacturing and Marketing Generic Drugs
Details : Sugammadex is a generic version of bridion which is indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
Product Name : Sugammadex Intravenous Solution
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 15, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Sugammadex Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,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.
PharmaCompass also assists you with knowing the Sugammadex Sodium API Price utilized in the formulation of products. Sugammadex Sodium API Price is not always fixed or binding as the Sugammadex Sodium Price is obtained through a variety of data sources. The Sugammadex Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bridion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bridion, including repackagers and relabelers. The FDA regulates Bridion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bridion 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 Bridion manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bridion supplier is an individual or a company that provides Bridion active pharmaceutical ingredient (API) or Bridion finished formulations upon request. The Bridion suppliers may include Bridion API manufacturers, exporters, distributors and traders.
click here to find a list of Bridion suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bridion DMF (Drug Master File) is a document detailing the whole manufacturing process of Bridion active pharmaceutical ingredient (API) in detail. Different forms of Bridion DMFs exist exist since differing nations have different regulations, such as Bridion USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bridion DMF submitted to regulatory agencies in the US is known as a USDMF. Bridion USDMF includes data on Bridion's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bridion USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bridion 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 Bridion Drug Master File in Japan (Bridion JDMF) empowers Bridion 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 Bridion JDMF during the approval evaluation for pharmaceutical products. At the time of Bridion 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 Bridion 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 Bridion Drug Master File in Korea (Bridion KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bridion. The MFDS reviews the Bridion KDMF as part of the drug registration process and uses the information provided in the Bridion KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bridion 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 Bridion API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bridion suppliers with KDMF on PharmaCompass.
A Bridion written confirmation (Bridion WC) is an official document issued by a regulatory agency to a Bridion manufacturer, verifying that the manufacturing facility of a Bridion active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bridion APIs or Bridion finished pharmaceutical products to another nation, regulatory agencies frequently require a Bridion WC (written confirmation) as part of the regulatory process.
click here to find a list of Bridion 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 Bridion as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bridion 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 Bridion 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 Bridion and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bridion NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bridion suppliers with NDC on PharmaCompass.
Bridion 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 Bridion GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Bridion GMP manufacturer or Bridion GMP API supplier for your needs.
A Bridion CoA (Certificate of Analysis) is a formal document that attests to Bridion's compliance with Bridion specifications and serves as a tool for batch-level quality control.
Bridion CoA mostly includes findings from lab analyses of a specific batch. For each Bridion 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.
Bridion may be tested according to a variety of international standards, such as European Pharmacopoeia (Bridion EP), Bridion JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bridion USP).
