01 2Sandoz B2B
01 17-PACA (7-AMINO-3-PROPENYL-CEPHALOSPORANIC ACID)
02 1PACA, PURE
01 2Switzerland
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10838
Submission : 1994-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18167
Submission : 2004-11-19
Status : Inactive
Type : II
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PharmaCompass offers a list of PACA 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 PACA manufacturer or PACA supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred PACA manufacturer or PACA supplier.
A PICA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PICA, including repackagers and relabelers. The FDA regulates PICA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PICA 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 PICA supplier is an individual or a company that provides PICA active pharmaceutical ingredient (API) or PICA finished formulations upon request. The PICA suppliers may include PICA API manufacturers, exporters, distributors and traders.
click here to find a list of PICA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A PICA DMF (Drug Master File) is a document detailing the whole manufacturing process of PICA active pharmaceutical ingredient (API) in detail. Different forms of PICA DMFs exist exist since differing nations have different regulations, such as PICA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PICA DMF submitted to regulatory agencies in the US is known as a USDMF. PICA USDMF includes data on PICA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PICA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PICA suppliers with USDMF on PharmaCompass.
