01 1Hetero Labs Limited
01 1Erlotinib Hydrochloride
01 1India
Registration Number : 304MF10037
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2022-02-17
Latest Date of Registration : 2022-11-09
A Erlotinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erlotinib Hydrochloride, including repackagers and relabelers. The FDA regulates Erlotinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erlotinib 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 Erlotinib Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Erlotinib Hydrochloride supplier is an individual or a company that provides Erlotinib Hydrochloride active pharmaceutical ingredient (API) or Erlotinib Hydrochloride finished formulations upon request. The Erlotinib Hydrochloride suppliers may include Erlotinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Erlotinib Hydrochloride 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 Erlotinib Hydrochloride Drug Master File in Japan (Erlotinib Hydrochloride JDMF) empowers Erlotinib Hydrochloride 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 Erlotinib Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Erlotinib Hydrochloride 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 Erlotinib Hydrochloride suppliers with JDMF on PharmaCompass.
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