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API SUPPLIERS
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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]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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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...
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
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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]Drugs in Development
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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
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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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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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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, 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 Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sugammadex Sodium, including repackagers and relabelers. The FDA regulates Sugammadex Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sugammadex Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sugammadex Sodium supplier is an individual or a company that provides Sugammadex Sodium active pharmaceutical ingredient (API) or Sugammadex Sodium finished formulations upon request. The Sugammadex Sodium suppliers may include Sugammadex Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Sugammadex Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sugammadex Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Sugammadex Sodium active pharmaceutical ingredient (API) in detail. Different forms of Sugammadex Sodium DMFs exist exist since differing nations have different regulations, such as Sugammadex Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sugammadex Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Sugammadex Sodium USDMF includes data on Sugammadex Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sugammadex Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sugammadex Sodium 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 Sodium Drug Master File in Japan (Sugammadex Sodium JDMF) empowers Sugammadex Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Sugammadex Sodium 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 Sodium 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 Sodium Drug Master File in Korea (Sugammadex Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sugammadex Sodium. The MFDS reviews the Sugammadex Sodium KDMF as part of the drug registration process and uses the information provided in the Sugammadex Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sugammadex Sodium 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 Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sugammadex Sodium suppliers with KDMF on PharmaCompass.
A Sugammadex Sodium written confirmation (Sugammadex Sodium WC) is an official document issued by a regulatory agency to a Sugammadex Sodium manufacturer, verifying that the manufacturing facility of a Sugammadex Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sugammadex Sodium APIs or Sugammadex Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Sugammadex Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Sugammadex Sodium 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 Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sugammadex Sodium 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 Sodium 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 Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sugammadex Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sugammadex Sodium suppliers with NDC on PharmaCompass.
Sugammadex Sodium 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 Sodium 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 Sodium GMP manufacturer or Sugammadex Sodium GMP API supplier for your needs.
A Sugammadex Sodium CoA (Certificate of Analysis) is a formal document that attests to Sugammadex Sodium's compliance with Sugammadex Sodium specifications and serves as a tool for batch-level quality control.
Sugammadex Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Sugammadex Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Sugammadex Sodium EP), Sugammadex Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sugammadex Sodium USP).
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