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