Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Granules India Limited
03 1TAPI Technology & API Services
04 2Alembic Pharmaceuticals Limited
05 1Aurobindo Pharma Limited
06 1Chongqing Carelife Pharmaceutical
07 3Cipla
08 1Hetero Drugs
09 3MSN Laboratories
10 2Natco Pharma
11 1Reliance Life Sciences Private Limited
12 1Sichuan Xieli Pharmaceutical
13 1Yabao Pharmaceutical Group Co. Ltd
14 1Zhejiang Jiuzhou Pharmaceutical
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-27
Pay. Date : 2018-01-19
DMF Number : 32140
Submission : 2017-12-20
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37229
Submission : 2022-06-30
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2016-02-01
DMF Number : 30234
Submission : 2016-02-23
Status :
Type : II
A Sorafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorafenib, including repackagers and relabelers. The FDA regulates Sorafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorafenib 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 Sorafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sorafenib supplier is an individual or a company that provides Sorafenib active pharmaceutical ingredient (API) or Sorafenib finished formulations upon request. The Sorafenib suppliers may include Sorafenib API manufacturers, exporters, distributors and traders.
click here to find a list of Sorafenib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sorafenib DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorafenib active pharmaceutical ingredient (API) in detail. Different forms of Sorafenib DMFs exist exist since differing nations have different regulations, such as Sorafenib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorafenib DMF submitted to regulatory agencies in the US is known as a USDMF. Sorafenib USDMF includes data on Sorafenib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorafenib USDMF is kept confidential to protect the manufacturer’s intellectual property.
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