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List of Korea Drug Master Files (KDMF) for Oxaliplatin Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Kyungbo Pharmaceutical Co., Ltd.
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Sanofi-Aventis Korea Co., Ltd.
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20120323-197-I-32-03
Veranova, L.P.
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Yuhan Corporation
2012-11-30
20121108-197-I-84-06(1)
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Pfizer Pharmaceuticals Korea Co., Ltd.
2012-11-26
20121108-197-I-84-06(2)
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2012-11-08
20121108-197-I-84-06
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2022-06-22
20121108-197-I-84-06(5)
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2012-12-21
20121108-197-I-84-06(3)
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Shinpoong Pharmaceutical Co., Ltd.
2014-04-11
20121108-197-I-84-06(4)
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Samyang Holdings Co., Ltd.
2017-02-28
20150413-197-I-440-11(A)
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20150413-197-I-440-11
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Chong Kun Dang Co., Ltd.
2014-03-10
20131129-197-I-348-10(1)
Kunming Guiyan Pharmaceut...
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Kunming Institute of Prec...
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Dasan Pharmaceutical Co., Ltd.
2013-11-29
20131129-197-I-348-10
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Wonpoong Pharmaceutical Co., Ltd.
2012-11-28
20121128-197-I-195-08
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Pharmapia Co., Ltd.
2015-07-31
20121128-197-I-195-08(3)
Qilu Pharmaceutical Co., ...
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Kookjeon Pharmaceutical Co., Ltd.
2015-07-03
20121128-197-I-195-08(2)
Qilu Pharmaceutical Co., ...
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Korea United Pharmaceutical Co., Ltd.
2013-05-27
20121128-197-I-195-08(1)
Qilu Pharmaceutical Co., ...
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No. 243, Gongyebei Road, ...
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Sampoong Pharmachem Co., Ltd.
2022-05-04
20121128-197-I-195-08(4)
Qilu Pharmaceutical Co., ...
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No. 23999 Gong Ye Bei Roa...
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Masung LS Co., Ltd.
2012-02-24
20120224-197-I-27-02
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Shinpoong Pharmaceutical Co., Ltd.
2014-04-11
20120224-197-I-27-02(1)
Shilpa Medicare Limited
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2013-11-08
20131108-197-I-175-09
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Pfizer Pharmaceuticals Korea Co., Ltd.
2019-04-04
20180403-197-I-530-13(1)
Umicore Argentina SA
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2018-04-03
20180403-197-I-530-13
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  • INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML)
  • INJECTABLE;INTRAVENOUS - 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INTRAVENOUS - 50MG/10ML (5MG/ML)
  • INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML)
  • INJECTABLE;INTRAVENOUS - 50MG/10ML (5MG/ML)

Looking for / Oxaliplatin API manufacturers, exporters & distributors?

Oxaliplatin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Oxaliplatin

Synonyms

(1r,2r)-cyclohexane-1,2-diamine;oxalic acid;platinum, Foloxatine, L-platin, Oxaliplatin,(s), Oxaliplatin, solid, Gsox

About Oxaliplatin

An organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane, and with an oxalate ligand which is displaced to yield active oxaliplatin derivatives. These derivatives form inter- and intra-strand DNA crosslinks that inhibit DNA replication and transcription. Oxaliplatin is an antineoplastic agent that is often administered with FLUOROURACIL and FOLINIC ACID in the treatment of metastatic COLORECTAL NEOPLASMS.

Oxaliplatin Manufacturers

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

Oxaliplatin Suppliers

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

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

Oxaliplatin KDMF

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

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

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

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

Oxaliplatin Manufacturers | Traders | Suppliers

Oxaliplatin Manufacturers, Traders, Suppliers 1
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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