01 1Olon S.p.A
01 1PAROMOMYCIN SULFATE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13576
Submission : 1998-09-01
Status : Active
Type : II
A Paromomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paromomycin, including repackagers and relabelers. The FDA regulates Paromomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paromomycin 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 Paromomycin supplier is an individual or a company that provides Paromomycin active pharmaceutical ingredient (API) or Paromomycin finished formulations upon request. The Paromomycin suppliers may include Paromomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Paromomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paromomycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Paromomycin active pharmaceutical ingredient (API) in detail. Different forms of Paromomycin DMFs exist exist since differing nations have different regulations, such as Paromomycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paromomycin DMF submitted to regulatory agencies in the US is known as a USDMF. Paromomycin USDMF includes data on Paromomycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paromomycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paromomycin suppliers with USDMF on PharmaCompass.
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