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
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PharmaCompass offers a list of Lapatinib Ditosylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lapatinib Ditosylate manufacturer or Lapatinib Ditosylate supplier for your needs.
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A Lapatinib Ditosylate,Tykerb manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lapatinib Ditosylate,Tykerb, including repackagers and relabelers. The FDA regulates Lapatinib Ditosylate,Tykerb manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lapatinib Ditosylate,Tykerb API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Lapatinib Ditosylate,Tykerb supplier is an individual or a company that provides Lapatinib Ditosylate,Tykerb active pharmaceutical ingredient (API) or Lapatinib Ditosylate,Tykerb finished formulations upon request. The Lapatinib Ditosylate,Tykerb suppliers may include Lapatinib Ditosylate,Tykerb API manufacturers, exporters, distributors and traders.
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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 Ditosylate,Tykerb Drug Master File in Japan (Lapatinib Ditosylate,Tykerb JDMF) empowers Lapatinib Ditosylate,Tykerb 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 Ditosylate,Tykerb JDMF during the approval evaluation for pharmaceutical products. At the time of Lapatinib Ditosylate,Tykerb JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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