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Looking for 1651179-04-2 / Zanubrutinib API manufacturers, exporters & distributors?

Zanubrutinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Zanubrutinib

Synonyms

1691249-45-2, Brukinsa, Bgb-3111, Zanubrutinib [inn], Zanubrutinib [usan], Ag9mhg098z

Cas Number

1651179-04-2

Unique Ingredient Identifier (UNII)

AG9MHG098Z

About Zanubrutinib

Zanubrutinib is an inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, zanubrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways, which leads to the 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 overexpressed in B-cell malignancies; it plays an important role in B-lymphocyte development, activation, signaling, proliferation and survival.

(R)-Zanubrutinib Manufacturers

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

(R)-Zanubrutinib Suppliers

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

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

(R)-Zanubrutinib USDMF

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

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

click here to find a list of (R)-Zanubrutinib suppliers with USDMF on PharmaCompass.

(R)-Zanubrutinib KDMF

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

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

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

click here to find a list of (R)-Zanubrutinib suppliers with KDMF on PharmaCompass.

(R)-Zanubrutinib 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 (R)-Zanubrutinib as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of (R)-Zanubrutinib suppliers with NDC on PharmaCompass.

(R)-Zanubrutinib GMP

(R)-Zanubrutinib 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 (R)-Zanubrutinib 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 (R)-Zanubrutinib GMP manufacturer or (R)-Zanubrutinib GMP API supplier for your needs.

(R)-Zanubrutinib CoA

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

(R)-Zanubrutinib CoA mostly includes findings from lab analyses of a specific batch. For each (R)-Zanubrutinib 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.

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