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

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01 ChemWerth Inc (1)

02 Cipla (1)

03 Emcure Pharmaceuticals (1)

04 Fresenius Kabi AB Brunna (1)

05 Novartis Pharmaceuticals Corporation (1)

06 Sai Phytoceuticals (1)

07 ScinoPharm Taiwan, Ltd (1)

08 Synbias Pharma Limited Liability Company (1)

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01 TOPOTECAN HCL (1)

02 TOPOTECAN HYDROCHLORIDE (6)

03 TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE (1)

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01 India (3)

02 Sweden (1)

03 Switzerland (1)

04 Taiwan (1)

05 U.S.A (1)

06 Ukraine (1)

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01 Active (4)

02 Inactive (4)

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01 Complete (2)

02 Blank (6)

URL Supplier Web Content
21621
Inactive
2008-07-17
N/A
II
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23443
Active
2010-01-11
N/A
II
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22303
Inactive
2009-01-06
N/A
II
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24458
Active
2011-02-02
N/A
II
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20723
Inactive
2007-06-20
N/A
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20810
Active
2007-08-22
Complete
2013-09-29
2013-09-18
II
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URL Supplier Web Content
23682
Inactive
2010-03-29
N/A
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Looking for 119413-54-6 / Topotecan Hydrochloride API manufacturers, exporters & distributors?

Topotecan Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Topotecan Hydrochloride

Synonyms

119413-54-6, Topotecan hcl, Hycamtin, Nogitecan hydrochloride, Topotecan (hydrochloride), Topotecan monohydrochloride

Cas Number

119413-54-6

Unique Ingredient Identifier (UNII)

956S425ZCY

About Topotecan Hydrochloride

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

Topotecan Manufacturers

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

Topotecan Suppliers

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

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

Topotecan USDMF

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

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

click here to find a list of Topotecan suppliers with USDMF on PharmaCompass.

Topotecan Manufacturers | Traders | Suppliers

Topotecan 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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