GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3401
Submission : 1978-12-28
Status : Inactive
Type : II
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A ortho Phthalaldehyde manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ortho Phthalaldehyde, including repackagers and relabelers. The FDA regulates ortho Phthalaldehyde manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ortho Phthalaldehyde 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 ortho Phthalaldehyde supplier is an individual or a company that provides ortho Phthalaldehyde active pharmaceutical ingredient (API) or ortho Phthalaldehyde finished formulations upon request. The ortho Phthalaldehyde suppliers may include ortho Phthalaldehyde API manufacturers, exporters, distributors and traders.
