01 1Fuxin Long Rui Pharmaceutical
02 1Lupin Ltd
03 1Viatris
01 2LEDIPASVIR
02 1LEDIPASVIR: PVP (1:1)
01 1China
02 1India
03 1U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33491
Submission : 2019-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34446
Submission : 2019-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33430
Submission : 2018-12-28
Status : Active
Type : II
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PharmaCompass offers a list of Ledipasvir 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 Ledipasvir manufacturer or Ledipasvir supplier for your needs.
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PharmaCompass also assists you with knowing the Ledipasvir API Price utilized in the formulation of products. Ledipasvir API Price is not always fixed or binding as the Ledipasvir Price is obtained through a variety of data sources. The Ledipasvir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 013TE6E4WV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 013TE6E4WV, including repackagers and relabelers. The FDA regulates 013TE6E4WV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 013TE6E4WV API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 013TE6E4WV supplier is an individual or a company that provides 013TE6E4WV active pharmaceutical ingredient (API) or 013TE6E4WV finished formulations upon request. The 013TE6E4WV suppliers may include 013TE6E4WV API manufacturers, exporters, distributors and traders.
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A 013TE6E4WV DMF (Drug Master File) is a document detailing the whole manufacturing process of 013TE6E4WV active pharmaceutical ingredient (API) in detail. Different forms of 013TE6E4WV DMFs exist exist since differing nations have different regulations, such as 013TE6E4WV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 013TE6E4WV DMF submitted to regulatory agencies in the US is known as a USDMF. 013TE6E4WV USDMF includes data on 013TE6E4WV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 013TE6E4WV USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 3 companies offering 013TE6E4WV
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