DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Ami Lifesciences Private Limited
03 1Biocon
04 2Changzhou Pharmaceutical Factory
05 1Lupin Ltd
06 1MSN Laboratories
07 1Mankind Pharma
08 1Raks Pharma
09 1Unichem Laboratories Limited
10 1Viatris
11 1Zhejiang Tianyu Pharmaceutical Co., Ltd
12 1Zhuhai Rundu Pharmaceutical
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 : 40307
Submission : 2024-08-28
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38140
Submission : 2023-03-17
Status :
Type : II
A Sacubitril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril, including repackagers and relabelers. The FDA regulates Sacubitril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril 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 Sacubitril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sacubitril supplier is an individual or a company that provides Sacubitril active pharmaceutical ingredient (API) or Sacubitril finished formulations upon request. The Sacubitril suppliers may include Sacubitril API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sacubitril DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril DMFs exist exist since differing nations have different regulations, such as Sacubitril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril USDMF includes data on Sacubitril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril suppliers with USDMF on PharmaCompass.
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