01 2Maithri Drugs
01 1LERCANIDIPINE HYDROCHLORIDE (AMORPHOUS)
02 1LERCANIDIPINE HYDROCHLORIDE (FORM-I)
01 2India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35609
Submission : 2021-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35507
Submission : 2020-12-30
Status : Active
Type : II
A Lercanidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lercanidipine, including repackagers and relabelers. The FDA regulates Lercanidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lercanidipine 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 Lercanidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lercanidipine supplier is an individual or a company that provides Lercanidipine active pharmaceutical ingredient (API) or Lercanidipine finished formulations upon request. The Lercanidipine suppliers may include Lercanidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Lercanidipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lercanidipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lercanidipine active pharmaceutical ingredient (API) in detail. Different forms of Lercanidipine DMFs exist exist since differing nations have different regulations, such as Lercanidipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lercanidipine DMF submitted to regulatory agencies in the US is known as a USDMF. Lercanidipine USDMF includes data on Lercanidipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lercanidipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lercanidipine suppliers with USDMF on PharmaCompass.
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