Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 1Olpha
02 1Cilag AG
03 1Blank
01 2RIMANTADINE HYDROCHLORIDE
02 1RIMANTADINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE CW-100
01 1Latvia
02 1Switzerland
03 1Blank
01 1Active
02 2Inactive
01 1Complete
02 2Blank
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-17
Pay. Date : 2012-11-27
DMF Number : 15210
Submission : 2000-12-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10233
Submission : 1993-05-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14936
Submission : 2000-06-22
Status : Inactive
Type : II
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A Rimantadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimantadine Hydrochloride, including repackagers and relabelers. The FDA regulates Rimantadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimantadine 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.
click here to find a list of Rimantadine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rimantadine Hydrochloride supplier is an individual or a company that provides Rimantadine Hydrochloride active pharmaceutical ingredient (API) or Rimantadine Hydrochloride finished formulations upon request. The Rimantadine Hydrochloride suppliers may include Rimantadine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Rimantadine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimantadine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimantadine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Rimantadine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Rimantadine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimantadine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Rimantadine Hydrochloride USDMF includes data on Rimantadine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimantadine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimantadine Hydrochloride suppliers with USDMF on PharmaCompass.
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