Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1Sichuan Elixir Pharmaceuticals
01 27-ETHYL-10-HYDROXYCAMPTOTHECIN
01 1China
02 1India
01 2Active
01 2Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39031
Submission : 2024-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39576
Submission : 2024-03-11
Status : Active
Type : II
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PharmaCompass offers a list of 7-Ethyl-10-Hydroxycamptothecin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 7-Ethyl-10-Hydroxycamptothecin manufacturer or 7-Ethyl-10-Hydroxycamptothecin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred 7-Ethyl-10-Hydroxycamptothecin manufacturer or 7-Ethyl-10-Hydroxycamptothecin supplier.
A SN38 API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SN38 API, including repackagers and relabelers. The FDA regulates SN38 API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SN38 API 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 SN38 API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A SN38 API supplier is an individual or a company that provides SN38 API active pharmaceutical ingredient (API) or SN38 API finished formulations upon request. The SN38 API suppliers may include SN38 API API manufacturers, exporters, distributors and traders.
click here to find a list of SN38 API suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A SN38 API DMF (Drug Master File) is a document detailing the whole manufacturing process of SN38 API active pharmaceutical ingredient (API) in detail. Different forms of SN38 API DMFs exist exist since differing nations have different regulations, such as SN38 API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SN38 API DMF submitted to regulatory agencies in the US is known as a USDMF. SN38 API USDMF includes data on SN38 API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SN38 API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SN38 API suppliers with USDMF on PharmaCompass.
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