Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ALP Pharm
01 1NAPHAZOLINE NITRATE
02 1NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE)
01 1China
02 1India
01 1Active
02 1Inactive
01 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41013
Submission : 2024-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23643
Submission : 2010-03-12
Status : Inactive
Type : II
A Naphazoline Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naphazoline Nitrate, including repackagers and relabelers. The FDA regulates Naphazoline Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naphazoline Nitrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Naphazoline Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naphazoline Nitrate supplier is an individual or a company that provides Naphazoline Nitrate active pharmaceutical ingredient (API) or Naphazoline Nitrate finished formulations upon request. The Naphazoline Nitrate suppliers may include Naphazoline Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Naphazoline Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naphazoline Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Naphazoline Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Naphazoline Nitrate DMFs exist exist since differing nations have different regulations, such as Naphazoline Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naphazoline Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Naphazoline Nitrate USDMF includes data on Naphazoline Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naphazoline Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naphazoline Nitrate suppliers with USDMF on PharmaCompass.
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