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Looking for 191732-72-6 / Lenalidomide API manufacturers, exporters & distributors?

Lenalidomide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lenalidomide

Synonyms

191732-72-6, Revlimid, Revimid, 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione, Cc-5013, Lenalidomide (cc-5013)

Cas Number

191732-72-6

Unique Ingredient Identifier (UNII)

F0P408N6V4

About Lenalidomide

A phthalimide and piperidone derivative that has immunomodulatory and antiangiogenic properties. It is used for the treatment of transfusion-dependent anemia in MYELODYSPLASTIC SYNDROMES, and for the treatment of MULTIPLE MYELOMA, and relapsed or refractory MANTLE CELL LYMPHOMA.

Lenalidomide Manufacturers

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

Lenalidomide Suppliers

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

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

Lenalidomide USDMF

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

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

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

Lenalidomide 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 Lenalidomide Drug Master File in Japan (Lenalidomide JDMF) empowers Lenalidomide 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 Lenalidomide JDMF during the approval evaluation for pharmaceutical products. At the time of Lenalidomide 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 Lenalidomide suppliers with JDMF on PharmaCompass.

Lenalidomide KDMF

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

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

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

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

Lenalidomide WC

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

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

Lenalidomide 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 Lenalidomide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Lenalidomide GMP

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

Lenalidomide CoA

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

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

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