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Looking for 577-11-7 / Docusate Sodium API manufacturers, exporters & distributors?

Docusate Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Docusate 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 Docusate Sodium manufacturer or Docusate Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Docusate Sodium manufacturer or Docusate Sodium supplier.

PharmaCompass also assists you with knowing the Docusate Sodium API Price utilized in the formulation of products. Docusate Sodium API Price is not always fixed or binding as the Docusate Sodium Price is obtained through a variety of data sources. The Docusate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Docusate Sodium

Synonyms

577-11-7, Dioctyl sodium sulfosuccinate, Dioctyl sulfosuccinate sodium salt, Aerosol ot, Constonate, Dioctylal

Cas Number

577-11-7

Unique Ingredient Identifier (UNII)

F05Q2T2JA0

About Docusate Sodium

All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate Manufacturers

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate, including repackagers and relabelers. The FDA regulates 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate Suppliers

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate supplier is an individual or a company that provides 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate active pharmaceutical ingredient (API) or 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate finished formulations upon request. The 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers may include 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate API manufacturers, exporters, distributors and traders.

click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate USDMF

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate active pharmaceutical ingredient (API) in detail. Different forms of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate DMFs exist exist since differing nations have different regulations, such as 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate DMF submitted to regulatory agencies in the US is known as a USDMF. 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate USDMF includes data on 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with USDMF on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate JDMF

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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate Drug Master File in Japan (1,4-Bis(2-ethylhexyl) sodium sulfosuccinate JDMF) empowers 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate JDMF during the approval evaluation for pharmaceutical products. At the time of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with JDMF on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate Drug Master File in Korea (1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate. The MFDS reviews the 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF as part of the drug registration process and uses the information provided in the 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate KDMF to evaluate the safety and efficacy of the drug.

After submitting a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with KDMF on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP of the European Pharmacopoeia monograph is often referred to as a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate Certificate of Suitability (COS). The purpose of a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate to their clients by showing that a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP has been issued for it. The manufacturer submits a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP holder for the record. Additionally, the data presented in the 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate DMF.

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with CEP (COS) on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate WC

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate written confirmation (1,4-Bis(2-ethylhexyl) sodium sulfosuccinate WC) is an official document issued by a regulatory agency to a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate manufacturer, verifying that the manufacturing facility of a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate APIs or 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate finished pharmaceutical products to another nation, regulatory agencies frequently require a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate WC (written confirmation) as part of the regulatory process.

click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with Written Confirmation (WC) on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate NDC

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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate suppliers with NDC on PharmaCompass.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate GMP

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate GMP manufacturer or 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate GMP API supplier for your needs.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CoA

A 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CoA (Certificate of Analysis) is a formal document that attests to 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate's compliance with 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate specifications and serves as a tool for batch-level quality control.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate CoA mostly includes findings from lab analyses of a specific batch. For each 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate 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.

1,4-Bis(2-ethylhexyl) sodium sulfosuccinate may be tested according to a variety of international standards, such as European Pharmacopoeia (1,4-Bis(2-ethylhexyl) sodium sulfosuccinate EP), 1,4-Bis(2-ethylhexyl) sodium sulfosuccinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1,4-Bis(2-ethylhexyl) sodium sulfosuccinate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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