01 1Aurobindo Pharma Limited
02 1Emcure Pharmaceuticals
03 2Hetero Drugs
04 2Lupin Ltd
05 1Maithri Drugs
06 2Viatris
01 3RALTEGRAVIR POTASSIUM
02 1RALTEGRAVIR POTASSIUM (FORM-III)
03 3RALTEGRAVIR POTASSIUM USP
04 1RALTEGRAVIR POTASSIUM USP (CRYSTALLINE)
05 1RALTEGRAVIR POTASSIUM USP (PROCESS-II)
01 7India
02 2U.S.A
01 7Active
02 2Inactive
01 5Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-14
Pay. Date : 2023-12-22
DMF Number : 39315
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26935
Submission : 2013-03-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-08
Pay. Date : 2023-01-10
DMF Number : 37182
Submission : 2022-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25261
Submission : 2011-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-15
Pay. Date : 2022-08-25
DMF Number : 34206
Submission : 2019-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25753
Submission : 2012-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36083
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-02
Pay. Date : 2016-06-21
DMF Number : 30595
Submission : 2016-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2013-12-09
DMF Number : 27728
Submission : 2013-12-24
Status : Active
Type : II
53
PharmaCompass offers a list of Raltegravir Potassium 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 Raltegravir Potassium manufacturer or Raltegravir Potassium supplier for your needs.
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PharmaCompass also assists you with knowing the Raltegravir Potassium API Price utilized in the formulation of products. Raltegravir Potassium API Price is not always fixed or binding as the Raltegravir Potassium Price is obtained through a variety of data sources. The Raltegravir Potassium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ISENTRESS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ISENTRESS, including repackagers and relabelers. The FDA regulates ISENTRESS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ISENTRESS 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 ISENTRESS manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ISENTRESS supplier is an individual or a company that provides ISENTRESS active pharmaceutical ingredient (API) or ISENTRESS finished formulations upon request. The ISENTRESS suppliers may include ISENTRESS API manufacturers, exporters, distributors and traders.
click here to find a list of ISENTRESS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ISENTRESS DMF (Drug Master File) is a document detailing the whole manufacturing process of ISENTRESS active pharmaceutical ingredient (API) in detail. Different forms of ISENTRESS DMFs exist exist since differing nations have different regulations, such as ISENTRESS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ISENTRESS DMF submitted to regulatory agencies in the US is known as a USDMF. ISENTRESS USDMF includes data on ISENTRESS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ISENTRESS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ISENTRESS suppliers with USDMF on PharmaCompass.
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