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

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01 Hetero Labs Limited (Unit-1) (2)

02 Jeil Pharmaceutical Co., Ltd. (1)

03 Pfizer Asia Manufacturing Pte. Ltd. (1)

04 Pfizer Cork Ltd (1)

05 Pfizer Ireland Pharmaceuticals (1)

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01 CTC Bio Co., Ltd. (1)

02 Iksoo Pharmaceutical Co., Ltd. (1)

03 Jeil Pharmaceutical Co., Ltd. (1)

04 Pfizer Pharmaceuticals Korea Co., Ltd. (3)

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01 sunitinib malate (6)

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01 South Korea (3)

02 U.S.A (3)

URL Supplier Web Content
Iksoo Pharmaceutical Co., Ltd.
2021-03-17
Number 69-9-ND
Hetero Labs Limited (Unit...
India
Sy.No.10, IDA,Gaddapothar...
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CTC Bio Co., Ltd.
2022-08-29
Number 69-9-ND(1)
Hetero Labs Limited (Unit...
India
Sy.No.10, IDA,Gaddapothar...
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Jeil Pharmaceutical Co., Ltd.
2013-08-29
21-11-ND
Jeil Pharmaceutical Co., ...
South Korea
7, Cheongganggachang-ro, ...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2015-07-29
Wed2582-20-ND
Pfizer Asia Manufacturing...
Singapore
31 Tuas South Avenue 6 Si...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2006-05-11
Number 189-2-ND
Pfizer Cork Ltd
Ireland
Inchera Little Island Co....
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Pfizer Pharmaceuticals Korea Co., Ltd.
2011-05-16
Wed189-12-ND
Pfizer Ireland Pharmaceut...
Ireland
PO Box 140, Ringaskiddy A...
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Looking for 341031-54-7 / Sunitinib API manufacturers, exporters & distributors?

Sunitinib manufacturers, exporters & distributors 1

55

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

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

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

API | Excipient name

Sunitinib

Synonyms

341031-54-7, Sutent, Su011248 l-malate salt, Sunitinib malate [usan], Pha-290940ad, Su010398

Cas Number

341031-54-7

Unique Ingredient Identifier (UNII)

LVX8N1UT73

About Sunitinib

An indole and pyrrole derivative that inhibits VEGFR-2 and PDGFR BETA RECEPTOR TYROSINE KINASES. It is used as an antineoplastic agent for the treatment of GASTROINTESTINAL STROMAL TUMORS, and for treatment of advanced or metastatic RENAL CELL CARCINOMA.

Sunitinib Malate Manufacturers

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

Sunitinib Malate Suppliers

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

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

Sunitinib Malate KDMF

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

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

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

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

Sunitinib Malate Manufacturers | Traders | Suppliers

Sunitinib Malate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Sunitinib Malate

Get in contact with the supplier of your choice:

  1. CTCBIO INC
  2. Jeil Pharmaceutical Co., Ltd
  3. Pfizer Inc
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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