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

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01 HETERO DRUGS LIMITED. (1)

02 Hamari PFST Co., Ltd. (1)

03 JEIL PHARMACEUTICAL CO. , LTD. (1)

04 Shin Poong Pharm. Co. , Ltd. (1)

05 Shiratori Pharmaceutical Co., Ltd. (1)

06 Shizuoka Caffeine Industry Co., Ltd. (2)

07 Syn-Tech Chem. & Pharm. Co. , Ltd. (1)

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01 Dedicated to tolvaptan production (1)

02 Tolvaptan (4)

03 Tolvaptan "D" (1)

04 Tolvaptan (amorphous) (manufacturing only) (1)

05 Tolvaptan (manufacturing only) (1)

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01 India (1)

02 Japan (4)

03 South Korea (2)

04 Taiwan (1)

URL Supplier Web Content
303MF10018
1-19-40 Nankokita, Suminoe-ku, Osak...
2021-01-26
2021-01-26
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301MF10051
7-2-A2, Hetero Corporate, Industria...
2019-08-20
2019-08-20
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303MF10006
343, Sapyeong-daero, Seocho-gu, Seo...
2021-01-14
2021-01-14
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303MF10013
161, Yeoksam-ro, Gangnam-gu, Seoul,...
2021-01-26
2021-01-26
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302MF10134
6-11-24 Tsudanuma, Narashino City, ...
2020-11-04
2020-11-04
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303MF10049
129 Suidocho, Aoi Ward, Shizuoka Ci...
2021-03-22
2021-03-22
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302MF10158
129 Suidocho, Aoi Ward, Shizuoka Ci...
2021-02-05
2020-12-23
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302MF10031
No. 168 Kai-Yuan Rd. , Hsin-Ying Ta...
2020-02-20
2020-02-20
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Looking for 150683-30-0 / Tolvaptan API manufacturers, exporters & distributors?

Tolvaptan manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tolvaptan

Synonyms

150683-30-0, Samsca, Opc-41061, Opc 41061, N-(4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1h-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide, N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide

Cas Number

150683-30-0

Unique Ingredient Identifier (UNII)

21G72T1950

About Tolvaptan

A benzazepine derivative and selective VASOPRESSIN V2 RECEPTOR antagonist that is used to treat euvolemic and hypervolemic HYPONATREMIA. It is also used in the treatment of rapidly progressing AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE to slow the rate of cyst development and renal insufficiency.

Tolvaptan Manufacturers

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

Tolvaptan Suppliers

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

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

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

Tolvaptan Manufacturers | Traders | Suppliers

Tolvaptan 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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