Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
01 1Shandong Loncom Pharmaceutical
02 1Honour Lab Limited
03 1Lupin Manufacturing Solutions
04 1ALP Pharm
05 1Alembic Pharmaceuticals Limited
06 1Alkem Laboratories
07 1Aurobindo Pharma Limited
08 1Biocompounds Pharmaceutical Inc
09 1Chromo Laboratories
10 1HEC Pharm
11 2Jiangxi Synergy Pharmaceutical
12 1Jubilant Generics
13 2MSN Laboratories
14 1Piramal Pharma Solutions
15 1Reyoung pharmaceutical
16 1Takeda Pharmaceutical
17 2Zhejiang Tianyu Pharmaceutical Co., Ltd
18 3Blank
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43759
Submission : 2026-03-13
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-08-08
DMF Number : 31895
Submission : 2017-11-28
Status :
Type : II
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-12
Pay. Date : 2019-06-05
DMF Number : 33732
Submission : 2019-04-17
Status :
Type : II
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A Edarbi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edarbi, including repackagers and relabelers. The FDA regulates Edarbi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edarbi API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Edarbi supplier is an individual or a company that provides Edarbi active pharmaceutical ingredient (API) or Edarbi finished formulations upon request. The Edarbi suppliers may include Edarbi API manufacturers, exporters, distributors and traders.
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A Edarbi DMF (Drug Master File) is a document detailing the whole manufacturing process of Edarbi active pharmaceutical ingredient (API) in detail. Different forms of Edarbi DMFs exist exist since differing nations have different regulations, such as Edarbi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edarbi DMF submitted to regulatory agencies in the US is known as a USDMF. Edarbi USDMF includes data on Edarbi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edarbi USDMF is kept confidential to protect the manufacturer’s intellectual property.
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