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
A PACA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PACA, including repackagers and relabelers. The FDA regulates PACA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PACA 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 PACA supplier is an individual or a company that provides PACA active pharmaceutical ingredient (API) or PACA finished formulations upon request. The PACA suppliers may include PACA API manufacturers, exporters, distributors and traders.
click here to find a list of PACA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PACA DMF (Drug Master File) is a document detailing the whole manufacturing process of PACA active pharmaceutical ingredient (API) in detail. Different forms of PACA DMFs exist exist since differing nations have different regulations, such as PACA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PACA DMF submitted to regulatory agencies in the US is known as a USDMF. PACA USDMF includes data on PACA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PACA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PACA suppliers with USDMF on PharmaCompass.
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