01 2Chugai Pharmaceutical
01 1CCA (LOBENZARIT SODIUM) BULK DRUG
02 1CCA (LOBENZARIT SODIUM) TABLETS
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7207
Submission : 1987-11-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7204
Submission : 1987-11-02
Status : Inactive
Type : II
A Lobenzarit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lobenzarit, including repackagers and relabelers. The FDA regulates Lobenzarit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lobenzarit 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 Lobenzarit supplier is an individual or a company that provides Lobenzarit active pharmaceutical ingredient (API) or Lobenzarit finished formulations upon request. The Lobenzarit suppliers may include Lobenzarit API manufacturers, exporters, distributors and traders.
click here to find a list of Lobenzarit suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lobenzarit DMF (Drug Master File) is a document detailing the whole manufacturing process of Lobenzarit active pharmaceutical ingredient (API) in detail. Different forms of Lobenzarit DMFs exist exist since differing nations have different regulations, such as Lobenzarit USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lobenzarit DMF submitted to regulatory agencies in the US is known as a USDMF. Lobenzarit USDMF includes data on Lobenzarit's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lobenzarit USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lobenzarit suppliers with USDMF on PharmaCompass.
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