01 1LUPIN LIMITED.
01 1Abacavir sulfate
01 1India
Registration Number : 229MF10171
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 4...
Initial Date of Registration : 2017-08-28
Latest Date of Registration : 2020-08-18
A Abacavir Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abacavir Sulfate, including repackagers and relabelers. The FDA regulates Abacavir Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abacavir Sulfate 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 Abacavir Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abacavir Sulfate supplier is an individual or a company that provides Abacavir Sulfate active pharmaceutical ingredient (API) or Abacavir Sulfate finished formulations upon request. The Abacavir Sulfate suppliers may include Abacavir Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Abacavir Sulfate 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 Abacavir Sulfate Drug Master File in Japan (Abacavir Sulfate JDMF) empowers Abacavir Sulfate 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 Abacavir Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Abacavir Sulfate 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 Abacavir Sulfate suppliers with JDMF on PharmaCompass.
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