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Looking for 50-35-1 / Thalidomide API manufacturers, exporters & distributors?

Thalidomide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Thalidomide

Synonyms

50-35-1, Thalomid, 2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione, (+/-)-thalidomide, Contergan, Distaval

Cas Number

50-35-1

Unique Ingredient Identifier (UNII)

4Z8R6ORS6L

About Thalidomide

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

Thalidomide Manufacturers

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

Thalidomide Suppliers

A Thalidomide supplier is an individual or a company that provides Thalidomide active pharmaceutical ingredient (API) or Thalidomide finished formulations upon request. The Thalidomide suppliers may include Thalidomide API manufacturers, exporters, distributors and traders.

click here to find a list of Thalidomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Thalidomide USDMF

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

A Thalidomide DMF submitted to regulatory agencies in the US is known as a USDMF. Thalidomide USDMF includes data on Thalidomide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thalidomide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Thalidomide suppliers with USDMF on PharmaCompass.

Thalidomide WC

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

click here to find a list of Thalidomide suppliers with Written Confirmation (WC) on PharmaCompass.

Thalidomide 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 Thalidomide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Thalidomide 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 Thalidomide 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 Thalidomide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Thalidomide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Thalidomide suppliers with NDC on PharmaCompass.

Thalidomide GMP

Thalidomide 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 Thalidomide 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 Thalidomide GMP manufacturer or Thalidomide GMP API supplier for your needs.

Thalidomide CoA

A Thalidomide CoA (Certificate of Analysis) is a formal document that attests to Thalidomide's compliance with Thalidomide specifications and serves as a tool for batch-level quality control.

Thalidomide CoA mostly includes findings from lab analyses of a specific batch. For each Thalidomide 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.

Thalidomide may be tested according to a variety of international standards, such as European Pharmacopoeia (Thalidomide EP), Thalidomide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Thalidomide 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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