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Looking for 19171-19-8 / Pomalidomide API manufacturers, exporters & distributors?

Pomalidomide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pomalidomide

Synonyms

19171-19-8, Actimid, 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione, Cc-4047, Pomalyst, Imnovid

Cas Number

19171-19-8

Unique Ingredient Identifier (UNII)

D2UX06XLB5

About Pomalidomide

Pomalidomide is an orally bioavailable derivative of thalidomide with potential immunomodulating, antiangiogenic and antineoplastic activities. Although its exact mechanism of action has yet to be fully elucidated, pomalidomide appears to inhibit TNF-alpha production, enhance the activity of T cells and natural killer (NK) cells and enhance antibody-dependent cellular cytotoxicity (ADCC). In addition, pomalidomide may inhibit tumor angiogenesis, promote cell cycle arrest in susceptible tumor cell populations, and stimulate erythropoeisis.

Actimid Manufacturers

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

Actimid Suppliers

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

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

Actimid USDMF

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

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

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

Actimid KDMF

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

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

After submitting a Actimid 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 Actimid API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Actimid suppliers with KDMF on PharmaCompass.

Actimid WC

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

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

Actimid 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 Actimid as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Actimid GMP

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

Actimid CoA

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

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

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