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List of Drug Master Files (KDMF) for Nilotinib Hydrochloride Monohydrate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Dr. Reddy's Laboratories Limited (1)

02 MSN Laboratories Private Limited (1)

03 Novartis Pharma AG@[sieving process] Novartis Pharma Stein AG (1)

04 PLIVA Croatia Ltd (1)

05 Sterling Pharma Ringaskiddy Limited@[Sifting Process]Novartis Pharma Stein AG (1)

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01 Farmirae Co., Ltd. (1)

02 Kookjeon Pharmaceutical Co., Ltd. (1)

03 Novartis Korea Co., Ltd. (2)

04 Samo Pharmaceutical Co., Ltd. (1)

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01 Nilotinib (1)

02 Nilotinib hydrochloride (1)

03 Nilotinib hydrochloride monohydrate (3)

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01 Croatia (1)

02 India (2)

03 Switzerland (2)

Farmirae Co., Ltd.
2024-01-23
Number 574-23-ND
Dr. Reddy's Laboratories ...
India
CTO Unit-VI, APIIC Indust...
URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2022-04-25
Wed173-36-ND
MSN Laboratories Private ...
India
(Unit-II), Sy.No.50, Kard...
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Novartis Korea Co., Ltd.
2007-12-04
Number 163-9-ND
Novartis Pharma AG@[sievi...
Switzerland
Lichtstrasse 35, 4056 Bas...
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Novartis Korea Co., Ltd.
2015-02-09
Wed2554-12-ND
Sterling Pharma Ringaskid...
Switzerland
Ringaskiddy, Cork, P43 FR...
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Samo Pharmaceutical Co., Ltd.
2022-10-18
Wed207-57-ND
PLIVA Croatia Ltd
Croatia
10291 Prigorje Brdovecko,...
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Looking for 923288-95-3 / Nilotinib API manufacturers, exporters & distributors?

Nilotinib manufacturers, exporters & distributors 1

53

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

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

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

API | Excipient name

Nilotinib

Synonyms

923288-95-3, Nilotinib hydrochloride anhydrous, Nilotinib hcl, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride, Nilotinib (hydrochloride), K37n7byx3x

Cas Number

923288-95-3

Unique Ingredient Identifier (UNII)

K37N7BYX3X

About Nilotinib

Nilotinib Hydrochloride Anhydrous is the hydrochloride salt of nilotinib, an orally bioavailable aminopyrimidine-derivative Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity. Designed to overcome imatinib resistance, nilotinib binds to and stabilizes the inactive conformation of the kinase domain of the Abl protein of the Bcr-Abl fusion protein, resulting in the inhibition of the Bcr-Abl-mediated proliferation of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) cells. This agent also inhibits the receptor tyrosine kinases platelet-derived growth factor receptor (PDGF-R) and c-kit, a receptor tyrosine kinase mutated and constitutively activated in most gastrointestinal stromal tumors (GISTs). With a binding mode that is energetically more favorable than that of imatinib, nilotinib has been shown to have an approximately 20-fold increased potency in kinase and proliferation assays compared to imatinib.

Nilotinib Hydrochloride Monohydrate Manufacturers

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

Nilotinib Hydrochloride Monohydrate Suppliers

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

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

Nilotinib Hydrochloride Monohydrate KDMF

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

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

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

click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with KDMF on PharmaCompass.

Nilotinib Hydrochloride Monohydrate Manufacturers | Traders | Suppliers

Nilotinib Hydrochloride Monohydrate Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Nilotinib Hydrochloride Monohydrate

Get in contact with the supplier of your choice:

  1. Dr. Reddy's Laboratories
  2. MSN Laboratories
  3. Novartis Pharmaceuticals Corporation
  4. Pliva Hrvatska
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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