DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Polpharma
03 1Ami Lifesciences Private Limited
04 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 1Amoli Organics
07 1Aurobindo Pharma Limited
08 1HONOUR LAB LTD
09 1Harman Finochem
10 2Jiangsu Lianhuan Pharmaceutical
11 1Laurus Labs
12 1Lupin Ltd
13 3MSN Laboratories
14 1Macleods Pharmaceuticals Limited
15 1Mankind Pharma
16 1Viatris
17 1Wisdom Pharmaceutical
18 1Zhejiang Tianyu Pharmaceutical Co., Ltd
19 1Zhuhai Rundu Pharmaceutical
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-22
Pay. Date : 2017-11-08
DMF Number : 31574
Submission : 2017-08-29
Status :
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-04
Pay. Date : 2017-12-20
DMF Number : 32337
Submission : 2017-12-21
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37994
Submission : 2023-03-09
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-12-20
DMF Number : 33457
Submission : 2019-02-28
Status :
Type : II
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A sacubitril valsartan sodium anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of sacubitril valsartan sodium anhydrous active pharmaceutical ingredient (API) in detail. Different forms of sacubitril valsartan sodium anhydrous DMFs exist exist since differing nations have different regulations, such as sacubitril valsartan sodium anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sacubitril valsartan sodium anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. sacubitril valsartan sodium anhydrous USDMF includes data on sacubitril valsartan sodium anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sacubitril valsartan sodium anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
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