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GDUFA

DMF Review : Complete

Rev. Date : 2015-01-08

Pay. Date : 2014-07-09

DMF Number : 27207

Submission : 2013-06-10

Status : Active

Type : II

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Looking for 30516-87-1 / Zidovudine API manufacturers, exporters & distributors?

Zidovudine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Zidovudine

Synonyms

Azidothymidine, 30516-87-1, 3'-azido-3'-deoxythymidine, Retrovir, Azt, Zidovudinum

Cas Number

30516-87-1

Unique Ingredient Identifier (UNII)

4B9XT59T7S

About Zidovudine

A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.

CZ0012 Manufacturers

A CZ0012 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CZ0012, including repackagers and relabelers. The FDA regulates CZ0012 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CZ0012 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 CZ0012 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

CZ0012 Suppliers

A CZ0012 supplier is an individual or a company that provides CZ0012 active pharmaceutical ingredient (API) or CZ0012 finished formulations upon request. The CZ0012 suppliers may include CZ0012 API manufacturers, exporters, distributors and traders.

click here to find a list of CZ0012 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

CZ0012 USDMF

A CZ0012 DMF (Drug Master File) is a document detailing the whole manufacturing process of CZ0012 active pharmaceutical ingredient (API) in detail. Different forms of CZ0012 DMFs exist exist since differing nations have different regulations, such as CZ0012 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A CZ0012 DMF submitted to regulatory agencies in the US is known as a USDMF. CZ0012 USDMF includes data on CZ0012's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CZ0012 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of CZ0012 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.