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API SUPPLIERS
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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
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]JDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 305MF10068
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2023-05-31
Latest Date of Registration : 2023-05-31
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2025-07-15
Valid Till : 2028-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operation
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
Date of Issue : 2024-01-23
Valid Till : 2026-06-17
Written Confirmation Number : WC-0476
Address of the Firm : K3/8, Anand Nagar, MIDC., Ambernath (East), Ambernath-421506, District: Thane, M...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2023-04-07
Valid Till : 2026-04-06
Written Confirmation Number : SD230030
Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong, PR China
Neuland Laboratories- A dedicated 100% API provider.
Date of Issue : 2025-06-16
Valid Till : 2028-06-16
Written Confirmation Number : WC-0036
Address of the Firm : (Unit-l), Sy.No.291, 346P, 347, 348P, 473, 474, 490/2, Veerabhadraswamy Temple R...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
About the Company : Since 2010, ASolution has remained committed to addressing pharmaceutical challenges of all scales with integrity, responsiveness, and timeliness. We strive to build long-term, mut...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Aspen API. More than just an API™
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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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
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Reddy
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 02/06/2022
Application Number : 20211119000032
Regulatory Info : Approved
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Aspen
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-03-15
Application Number : 88555
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Aspen
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 13/04/2023
Application Number : 20220404000015
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Orion
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 20/04/2023
Application Number : 20211025000034
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Orion
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-03-28
Application Number : 88751
Regulatory Info : Authorized
Registration Country : Spain
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
Actylis
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DATA COMPILATION #PharmaFlow
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Regulatory FDF Prices
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US Patents
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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 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, COA and API Price 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, COA and API Price 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, API price, 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).
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