Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1Allied chemical Corp
03 2Apothecon Pharmaceuticals
04 2Archimica
05 1Aurobindo Pharma Limited
06 1Cadila Pharmaceuticals
07 1Chemeca Drugs
08 1DK Pharmachem Pvt. Ltd
09 1Daiwa Pharmaceuticals
10 1Glenmark Life Sciences
11 2Hetero Drugs
12 1Macleods Pharmaceuticals Limited
13 1Plantex Ltd.
14 1S.C. POLIPHARMA INDUSTRIES S.R.L.
15 1Shandong Weifang Pharma Factory Co., Ltd
16 1Siegfried AG
17 1Solara Active Pharma Sciences
18 1Sumitomo Chemical
19 1Tokuyama Corporation
20 1Unichem Laboratories Limited
21 1Wanbury Limited
22 1Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-02
Pay. Date : 2020-03-05
DMF Number : 34452
Submission : 2019-12-24
Status :
Type : II
A Hyperex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyperex, including repackagers and relabelers. The FDA regulates Hyperex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyperex 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 Hyperex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyperex supplier is an individual or a company that provides Hyperex active pharmaceutical ingredient (API) or Hyperex finished formulations upon request. The Hyperex suppliers may include Hyperex API manufacturers, exporters, distributors and traders.
click here to find a list of Hyperex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyperex DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyperex active pharmaceutical ingredient (API) in detail. Different forms of Hyperex DMFs exist exist since differing nations have different regulations, such as Hyperex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyperex DMF submitted to regulatory agencies in the US is known as a USDMF. Hyperex USDMF includes data on Hyperex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyperex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyperex suppliers with USDMF on PharmaCompass.
We have 21 companies offering Hyperex
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