DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Maithri Drugs
01 2ROXADUSTAT
02 1ROXADUSTAT L-PROLINE
01 3India
01 3Active
01 1Complete
02 2Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-30
DMF Number : 34666
Submission : 2020-03-31
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35463
Submission : 2020-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36797
Submission : 2022-02-16
Status : Active
Type : II
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PharmaCompass offers a list of Roxadustat 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 Roxadustat manufacturer or Roxadustat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roxadustat manufacturer or Roxadustat supplier.
PharmaCompass also assists you with knowing the Roxadustat API Price utilized in the formulation of products. Roxadustat API Price is not always fixed or binding as the Roxadustat Price is obtained through a variety of data sources. The Roxadustat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Roxadustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxadustat, including repackagers and relabelers. The FDA regulates Roxadustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxadustat 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 Roxadustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Roxadustat supplier is an individual or a company that provides Roxadustat active pharmaceutical ingredient (API) or Roxadustat finished formulations upon request. The Roxadustat suppliers may include Roxadustat API manufacturers, exporters, distributors and traders.
click here to find a list of Roxadustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Roxadustat DMF (Drug Master File) is a document detailing the whole manufacturing process of Roxadustat active pharmaceutical ingredient (API) in detail. Different forms of Roxadustat DMFs exist exist since differing nations have different regulations, such as Roxadustat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Roxadustat DMF submitted to regulatory agencies in the US is known as a USDMF. Roxadustat USDMF includes data on Roxadustat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roxadustat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Roxadustat suppliers with USDMF on PharmaCompass.
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