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List of Drug Master Files (JDMF) for Pitavastatin Calcium Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 API Corporation Co., Ltd. (3)

02 Ace Japan Co., Ltd. (1)

03 Active Pharma Co., Ltd. (3)

04 Boryung Pharmaceutical Co. , Ltd. (1)

05 Daito Co., Ltd. (2)

06 ESTECHPHARMA CO. , LTD. (1)

07 KOLON LIFE SCIENCE, INC. (3)

08 Kyongbo Pharmaceutical Co. , Ltd. (2)

09 Mylan Laboratories Limited (1)

10 Nissan Chemical Co., Ltd. (2)

11 Solara Active Pharma Sciences Limited (1)

12 Strides Shasun Limited (1)

13 Zydus Cadila Healthcare Ltd. (1)

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01 Japanese Pharmacopoeia Pitavastatin Calcium Hydrate (1)

02 Pitavastatin Calcium (1)

03 Pitavastatin Calcium Hydrate (1)

04 Pitavastatin Calcium Hydrate M (1)

05 Pitavastatin calcium (7)

06 Pitavastatin calcium (1)

07 Pitavastatin calcium "A" (1)

08 Pitavastatin calcium (C) (1)

09 Pitavastatin calcium (Y) (1)

10 Pitavastatin calcium (production only) (1)

11 Pitavastatin calcium C (1)

12 Pitavastatin calcium KB (1)

13 Pitavastatin calcium KJ (1)

14 Pitavastatin calcium hydrate (2)

15 Pitavastatin calcium hydrate (1)

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01 Gabon (1)

02 India (2)

03 Japan (11)

04 South Korea (7)

05 U.S.A (1)

URL Supplier Web Content
303MF10052
5850-1 Higashineko, Higashine City,...
2021-03-26
2021-03-26
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229MF10194
2-36-1 Kanda Jimbocho, Chiyoda-ku, ...
2017-11-07
2017-11-07
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229MF10090
1-13-4 Uchikanda, Chiyoda-ku, Tokyo
2020-04-02
2017-05-01
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303MF10039
1-13-4 Uchikanda, Chiyoda-ku, Tokyo
2021-02-24
2021-02-24
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302MF10150
110, MAGOKDONG-RO, GANGSEO-GU, SEOU...
2020-12-15
2020-12-15
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304MF10079
174, Sirok-ro, Asan-si, Chungcheong...
2022-05-25
2022-05-25
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223MF10122
2-5-1 Nihonbashi, Chuo-ku, Tokyo
2015-05-25
2011-07-28
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304MF10026
2-36-1 Kanda Jimbocho, Chiyoda-ku, ...
2022-02-02
2022-02-02
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224MF10148
2nd Floor, Admin Block 27, Vandaloo...
2023-10-12
2012-07-31
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227MF10223
Plot No. 564/A/22, Road No. 92, Jub...
2015-08-31
2015-08-31
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Looking for 147526-32-7 / Pitavastatin API manufacturers, exporters & distributors?

Pitavastatin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Pitavastatin 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 Pitavastatin manufacturer or Pitavastatin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pitavastatin manufacturer or Pitavastatin supplier.

PharmaCompass also assists you with knowing the Pitavastatin API Price utilized in the formulation of products. Pitavastatin API Price is not always fixed or binding as the Pitavastatin Price is obtained through a variety of data sources. The Pitavastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Pitavastatin

Synonyms

Pitavastatin calcium, 147526-32-7, Livalo, Nisvastatin, Nk-104, Itavastatin calcium

Cas Number

147526-32-7

Unique Ingredient Identifier (UNII)

IYD54XEG3W

About Pitavastatin

Pitavastatin Calcium is a calcium salt formulation of pitavastatin, a novel statin that induces plaque regression and elevates HDL-cholesterol levels.

Pitavastatin Calcium Manufacturers

A Pitavastatin Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitavastatin Calcium, including repackagers and relabelers. The FDA regulates Pitavastatin Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitavastatin Calcium 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 Pitavastatin Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Pitavastatin Calcium Suppliers

A Pitavastatin Calcium supplier is an individual or a company that provides Pitavastatin Calcium active pharmaceutical ingredient (API) or Pitavastatin Calcium finished formulations upon request. The Pitavastatin Calcium suppliers may include Pitavastatin Calcium API manufacturers, exporters, distributors and traders.

click here to find a list of Pitavastatin Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Pitavastatin Calcium JDMF

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 Pitavastatin Calcium Drug Master File in Japan (Pitavastatin Calcium JDMF) empowers Pitavastatin Calcium 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 Pitavastatin Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Pitavastatin Calcium 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 Pitavastatin Calcium suppliers with JDMF on PharmaCompass.

Pitavastatin Calcium Manufacturers | Traders | Suppliers

Pitavastatin Calcium Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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