Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Dr. Reddy's Laboratories
03 1Porton Pharma Solutions
04 1Aurisco Pharmaceutical
05 1BDR Lifesciences
06 1Beijing Hope Pharmaceutical
07 1Changzhou Pharmaceutical Factory
08 1Cipla
09 1Intas Pharmaceuticals
10 1Lee Pharma
11 1MSN Laboratories
01 11RELUGOLIX
01 4China
02 6India
03 1Spain
01 11Active
01 6Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37795
Submission : 2022-12-23
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-05
Pay. Date : 2024-07-10
DMF Number : 39507
Submission : 2024-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39995
Submission : 2024-06-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-24
Pay. Date : 2024-07-08
DMF Number : 38488
Submission : 2024-07-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-22
Pay. Date : 2024-07-19
DMF Number : 40209
Submission : 2024-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39161
Submission : 2023-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-29
Pay. Date : 2024-08-08
DMF Number : 39608
Submission : 2024-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-12
Pay. Date : 2024-07-23
DMF Number : 40244
Submission : 2024-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37365
Submission : 2022-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-30
Pay. Date : 2024-09-24
DMF Number : 40461
Submission : 2024-09-26
Status : Active
Type : II
A Relugolix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Relugolix, including repackagers and relabelers. The FDA regulates Relugolix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Relugolix 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 Relugolix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Relugolix supplier is an individual or a company that provides Relugolix active pharmaceutical ingredient (API) or Relugolix finished formulations upon request. The Relugolix suppliers may include Relugolix API manufacturers, exporters, distributors and traders.
click here to find a list of Relugolix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Relugolix DMF (Drug Master File) is a document detailing the whole manufacturing process of Relugolix active pharmaceutical ingredient (API) in detail. Different forms of Relugolix DMFs exist exist since differing nations have different regulations, such as Relugolix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Relugolix DMF submitted to regulatory agencies in the US is known as a USDMF. Relugolix USDMF includes data on Relugolix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Relugolix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Relugolix suppliers with USDMF on PharmaCompass.
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