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Virtual BoothTAPI, 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 : 2017-07-05

Pay. Date : 2017-04-17

DMF Number : 31631

Submission : 2017-06-08

Status : Active

Type : II

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Looking for 936563-96-1 / Ibrutinib API manufacturers, exporters & distributors?

Ibrutinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ibrutinib

Synonyms

936563-96-1, Pci-32765, Imbruvica, Pci 32765, Ibrutinib (pci-32765), Pci-32765 (ibrutinib)

Cas Number

936563-96-1

Unique Ingredient Identifier (UNII)

1X70OSD4VX

About Ibrutinib

Ibrutinib is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon oral administration, ibrutinib binds to and irreversibly inhibits BTK activity, thereby preventing both B-cell activation and B-cell-mediated signaling. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is required for B cell receptor signaling, plays a key role in B-cell maturation, and is overexpressed in a number of B-cell malignancies. The expression of BTK in tumor cells is also associated with increased proliferation and survival.

Ibrutinib Manufacturers

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

Ibrutinib Suppliers

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

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

Ibrutinib USDMF

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

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

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

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.