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List of Drug Master Files (DMF) of Oxaliplatin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Veranova (1)

02 Cipla (1)

03 Emcure Pharmaceuticals (1)

04 Fresenius Kabi AB Brunna (1)

05 Heraeus Holding (2)

06 Hetero Drugs (1)

07 Hospira, Inc. (1)

08 Hubei Haosun Pharmaceutical Co., Ltd. (1)

09 JARI Pharmaceutical Co., Ltd. (1)

10 Jiangsu Hengrui Medicine (1)

11 KUNMING GUIYAN PHARMACEUTICAL CO., LTD. CN 650 033 Kunming (1)

12 Laurus Labs (1)

13 Mac-Chem Products (India) Pvt.Ltd (1)

14 Pliva Hrvatska (1)

15 Polymed Therapeutics Inc. (1)

16 Qilu Pharmaceutical (1)

17 Shilpa Medicare (1)

18 Sun Pharmaceutical Industries Limited (1)

19 TANAKA KIKINZOKU KOGYO (1)

20 Teva API (1)

21 Umicore (1)

22 VUAB Pharma A.S. (1)

23 Zhejiang Hisun Pharmaceutical (1)

24 Zydus Lifesciences (1)

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01 OXALIPLATIN (9)

02 OXALIPLATIN DRUG SUBSTANCE (2)

03 OXALIPLATIN PH EUR (1)

04 OXALIPLATIN PH. EUR. (1)

05 OXALIPLATIN PROCESS HER-2 USP (1)

06 OXALIPLATIN USP (9)

07 OXALIPLATIN USP (NON-STERILE API) (1)

08 OXALIPLATIN, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 China (6)

02 Croatia (1)

03 Czech Republic (1)

04 Germany (3)

05 India (8)

06 Israel (1)

07 Japan (1)

08 Sweden (1)

09 U.S.A (3)

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01 Active (19)

02 Inactive (6)

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01 Complete (11)

02 Blank (14)

URL Supplier Web Content
19610
Active
2006-07-17
Complete
2014-12-19
2014-12-16
II
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20054
Active
2006-12-19
Complete
2013-01-08
2012-12-21
II
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19633
Active
2006-07-28
Complete
2013-01-08
2012-12-21
II
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20665
Active
2007-07-09
Complete
2013-06-03
2012-12-24
II
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22387
Active
2008-12-22
Complete
2013-05-01
2013-04-17
II
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19594
Active
2006-07-11
N/A
II
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19648
Active
2006-08-04
N/A
II
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10040
Active
1993-01-15
N/A
II
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URL Supplier Web Content
19559
Active
2006-06-28
Complete
2012-12-24
2012-12-03
II
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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 USDMF

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

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

click here to find a list of Oxaliplatin 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.
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