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