01 1SIGMA TAU
02 1Sigma-Aldrich Corporation
01 1L-ORNITHINE HCL
02 1POLY-L-ORNITHINE HYDROCHLORIDE
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4729
Submission : 1982-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35111
Submission : 2021-01-08
Status : Active
Type : II
A Ornithine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ornithine hydrochloride, including repackagers and relabelers. The FDA regulates Ornithine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ornithine 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 Ornithine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ornithine hydrochloride supplier is an individual or a company that provides Ornithine hydrochloride active pharmaceutical ingredient (API) or Ornithine hydrochloride finished formulations upon request. The Ornithine hydrochloride suppliers may include Ornithine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ornithine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ornithine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ornithine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ornithine hydrochloride DMFs exist exist since differing nations have different regulations, such as Ornithine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ornithine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ornithine hydrochloride USDMF includes data on Ornithine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ornithine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ornithine hydrochloride suppliers with USDMF on PharmaCompass.
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