01 1Oranomed
01 1212Pb RADIOLABEL DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32094
Submission : 2017-09-20
Status : Active
Type : II
81
PharmaCompass offers a list of Lead API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lead manufacturer or Lead supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lead manufacturer or Lead supplier.
PharmaCompass also assists you with knowing the Lead API Price utilized in the formulation of products. Lead API Price is not always fixed or binding as the Lead Price is obtained through a variety of data sources. The Lead Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lead manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lead, including repackagers and relabelers. The FDA regulates Lead manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lead API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lead supplier is an individual or a company that provides Lead active pharmaceutical ingredient (API) or Lead finished formulations upon request. The Lead suppliers may include Lead API manufacturers, exporters, distributors and traders.
click here to find a list of Lead suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lead DMF (Drug Master File) is a document detailing the whole manufacturing process of Lead active pharmaceutical ingredient (API) in detail. Different forms of Lead DMFs exist exist since differing nations have different regulations, such as Lead USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lead DMF submitted to regulatory agencies in the US is known as a USDMF. Lead USDMF includes data on Lead's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lead USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lead suppliers with USDMF on PharmaCompass.
