01 1Hetero Labs Limited
01 1Lapatinib tosilate hydrate [D]
01 1India
Lapatinib tosylate hydrate [D]
Registration Number : 304MF10087
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2022-06-22
Latest Date of Registration : 2022-06-22
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Lapatinib Drug Master File in Japan (Lapatinib JDMF) empowers Lapatinib API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Lapatinib JDMF during the approval evaluation for pharmaceutical products. At the time of Lapatinib JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Lapatinib suppliers with JDMF on PharmaCompass.
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