ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Minakem (formerly Delmar Chemicals)
03 1Granules India Limited
04 1ALP Pharm
05 1Cambrex Corporation
06 1Formosa Laboratories
07 1Hetero Drugs
08 1MSN Laboratories
09 1ScinoPharm Taiwan, Ltd
10 1Sichuan Xieli Pharmaceutical
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34836
Submission : 2021-02-05
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-01-24
DMF Number : 32266
Submission : 2018-01-17
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36602
Submission : 2022-01-24
Status :
Type : II
A Lapatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lapatinib, including repackagers and relabelers. The FDA regulates Lapatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lapatinib 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 Lapatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lapatinib supplier is an individual or a company that provides Lapatinib active pharmaceutical ingredient (API) or Lapatinib finished formulations upon request. The Lapatinib suppliers may include Lapatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Lapatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lapatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Lapatinib active pharmaceutical ingredient (API) in detail. Different forms of Lapatinib DMFs exist exist since differing nations have different regulations, such as Lapatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lapatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Lapatinib USDMF includes data on Lapatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lapatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lapatinib suppliers with USDMF on PharmaCompass.
We have 10 companies offering Lapatinib
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