01 1Ace Japan Co., Ltd.
02 3Active Pharma Inc.
03 1Boryung Pharmaceutical Co. , Ltd.
04 2Daito Co., Ltd.
05 3KOLON LIFE SCIENCE, INC.
06 2Kyongbo Pharmaceutical Co. , Ltd.
07 2Nissan Chemical Corporation
08 1Polaris AI Pharma Corp.
09 1Solara Active Pharma Sciences Limited
10 1Strides Shasun Limited
11 1Tianish Laboratories Private Limited
12 3UBE Inc.
13 1Zydus Cadila Healthcare Ltd.
01 1Japanese Pharmacopoeia Pitavastatin Calcium Hydrate
02 1Pitavastatin Calcium
03 1Pitavastatin Calcium Hydrate
04 1Pitavastatin Calcium Hydrate M
05 7Pitavastatin calcium
06 1Pitavastatin calcium
07 1Pitavastatin calcium "A"
08 1Pitavastatin calcium (C)
09 1Pitavastatin calcium (Y)
10 1Pitavastatin calcium (production only)
11 1Pitavastatin calcium C
12 1Pitavastatin calcium KB
13 1Pitavastatin calcium KJ
14 2Pitavastatin calcium hydrate
15 1Pitavastatin calcium hydrate
01 1Gabon
02 2India
03 11Japan
04 7South Korea
05 1U.S.A
Japanese Pharmacopoeia Pitavastatin Calcium Hydrate
Registration Number : 303MF10052
Registrant's Address : Yamagata Prefecture Higashine City Higashine City 5850-1
Initial Date of Registration : 2021-03-26
Latest Date of Registration : 2021-03-26
Registration Number : 229MF10194
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2017-11-07
Latest Date of Registration : 2017-11-07
Registration Number : 303MF10039
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2021-02-24
Latest Date of Registration : 2021-02-24
Registration Number : 229MF10090
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2017-05-01
Latest Date of Registration : 2020-04-02
Registration Number : 302MF10150
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2020-12-15
Latest Date of Registration : 2020-12-15
Pitavastatin calcium hydrate "KBP"
Registration Number : 304MF10079
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2022-05-25
Latest Date of Registration : 2022-05-25
Registration Number : 223MF10122
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-07-28
Latest Date of Registration : 2015-05-25
Pitavastatin calcium hydrate M
Registration Number : 304MF10026
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2022-02-02
Latest Date of Registration : 2022-02-02
Registration Number : 224MF10148
Registrant's Address : 2nd Floor, Admin Block 27, Vandalooor kelambakkam Road, Keelakottaiyur Village, Melak...
Initial Date of Registration : 2012-07-31
Latest Date of Registration : 2023-10-12
Registration Number : 227MF10223
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2015-08-31
Latest Date of Registration : 2015-08-31
A Redevant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Redevant, including repackagers and relabelers. The FDA regulates Redevant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Redevant 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 Redevant supplier is an individual or a company that provides Redevant active pharmaceutical ingredient (API) or Redevant finished formulations upon request. The Redevant suppliers may include Redevant 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 Redevant Drug Master File in Japan (Redevant JDMF) empowers Redevant 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 Redevant JDMF during the approval evaluation for pharmaceutical products. At the time of Redevant 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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