Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Catalytica
03 1NORDIC SYNTHESIS AB
04 1Napp Technologies
05 1SIMS Srl
06 1Siegfried AG
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19991
Submission : 2006-11-22
Status :
Type : II
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A ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1, including repackagers and relabelers. The FDA regulates ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 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 ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 supplier is an individual or a company that provides ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 active pharmaceutical ingredient (API) or ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 finished formulations upon request. The ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 suppliers may include ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 API manufacturers, exporters, distributors and traders.
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A ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 active pharmaceutical ingredient (API) in detail. Different forms of ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 DMFs exist exist since differing nations have different regulations, such as ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 DMF submitted to regulatory agencies in the US is known as a USDMF. ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 USDMF includes data on ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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