01 1Avid Bioservices, Inc.
02 1Catalent Indiana, LLC
01 1Bol Hyaluronidase Alpha (Genetical Recombination)
02 1Borhyaluronidase alpha (genetical recombination)
01 2U.S.A
Borhyaluronidase alpha (genetical recombination)
Registration Number : 304MF10126
Registrant's Address : 14191 Myford Road Tustin, CA 92780, USA
Initial Date of Registration : 2022-08-24
Latest Date of Registration : 2022-08-24
Borhyaluronidase alpha (genetical recombination)
Registration Number : 302MF10030
Registrant's Address : 1300 South Patterson Drive, Bloomington, Indiana 47403 USA
Initial Date of Registration : 2020-02-20
Latest Date of Registration : 2021-09-02
A Hyaluronidase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyaluronidase, including repackagers and relabelers. The FDA regulates Hyaluronidase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyaluronidase 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 Hyaluronidase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyaluronidase supplier is an individual or a company that provides Hyaluronidase active pharmaceutical ingredient (API) or Hyaluronidase finished formulations upon request. The Hyaluronidase suppliers may include Hyaluronidase API manufacturers, exporters, distributors and traders.
click here to find a list of Hyaluronidase 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 Hyaluronidase Drug Master File in Japan (Hyaluronidase JDMF) empowers Hyaluronidase 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 Hyaluronidase JDMF during the approval evaluation for pharmaceutical products. At the time of Hyaluronidase 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 Hyaluronidase suppliers with JDMF on PharmaCompass.
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