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
A Raltegravir Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Raltegravir Potassium, including repackagers and relabelers. The FDA regulates Raltegravir Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Raltegravir Potassium 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 Raltegravir Potassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Raltegravir Potassium supplier is an individual or a company that provides Raltegravir Potassium active pharmaceutical ingredient (API) or Raltegravir Potassium finished formulations upon request. The Raltegravir Potassium suppliers may include Raltegravir Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Raltegravir Potassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Raltegravir Potassium DMF (Drug Master File) is a document detailing the whole manufacturing process of Raltegravir Potassium active pharmaceutical ingredient (API) in detail. Different forms of Raltegravir Potassium DMFs exist exist since differing nations have different regulations, such as Raltegravir Potassium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Raltegravir Potassium DMF submitted to regulatory agencies in the US is known as a USDMF. Raltegravir Potassium USDMF includes data on Raltegravir Potassium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Raltegravir Potassium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Raltegravir Potassium suppliers with USDMF on PharmaCompass.
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