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

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01 Aurobindo Pharma Limited (1)

02 Cipla (3)

03 Hetero Drugs (2)

04 Innovare Labs (1)

05 Johnson & Johnson Innovative Medicine (1)

06 Laurus Labs (1)

07 Lupin Ltd (2)

08 MSN Laboratories (2)

09 Raks Pharma (1)

10 Viatris (2)

11 Zhejiang Jiuzhou Pharmaceutical (2)

12 Zydus Lifesciences (1)

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01 DARUNAVIR (8)

02 DARUNAVIR (AMORPHOUS) (2)

03 DARUNAVIR (PROCESS-II) (1)

04 DARUNAVIR (R319064) DRUG SUBSTANCE (1)

05 DARUNAVIR AMORPHOUS (1)

06 DARUNAVIR AMORPHOUS (PROCESS-II) (1)

07 DARUNAVIR HYDRATE (1)

08 DARUNAVIR HYDRATE (PROCESS II) (1)

09 DARUNAVIR N-PROPANOLATE (1)

10 DARUNAVIR PROPYLENE GLYCOLATE (1)

11 DARUNAVIR [ROUTE CODE - "DI"] (1)

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01 China (2)

02 India (14)

03 U.S.A (3)

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01 Active (14)

02 Inactive (5)

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01 Complete (9)

02 Blank (10)

URL Supplier Web Content
23660
Active
2011-03-16
Complete
2013-09-29
2013-09-20
II
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URL Supplier Web Content
23661
Active
2010-07-06
Complete
2013-09-29
2013-09-20
II
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URL Supplier Web Content
23854
Active
2010-06-02
N/A
II
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URL Supplier Web Content
18825
Active
2005-11-02
N/A
II
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URL Supplier Web Content
31198
Active
2017-10-24
Complete
2017-11-03
2016-12-20
II
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URL Supplier Web Content
30882
Active
2016-10-05
Complete
2018-03-27
2018-03-14
II
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URL Supplier Web Content
27038
Active
2013-04-20
N/A
II
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URL Supplier Web Content
30803
Active
2016-10-05
Complete
2017-01-19
2016-09-30
II
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URL Supplier Web Content
23873
Active
2010-06-10
N/A
II
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URL Supplier Web Content
30596
Active
2016-06-27
Complete
2016-07-19
2016-06-21
II
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Looking for 206361-99-1 / Darunavir API manufacturers, exporters & distributors?

Darunavir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Darunavir

Synonyms

206361-99-1, Tmc114, Tmc-114, Prezista, Uic-94017, Tmc 114

Cas Number

206361-99-1

Unique Ingredient Identifier (UNII)

YO603Y8113

About Darunavir

An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.

Darunavir Manufacturers

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

Darunavir Suppliers

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

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

Darunavir USDMF

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

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

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

Darunavir Manufacturers | Traders | Suppliers

Darunavir 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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