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List of Drug Master Files (KDMF) for Tolvaptan Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Jeil Pharmaceutical Co., Ltd. (1)

02 Lupin Ltd (1)

03 Otsuka Pharmaceutial Co., Ltd (Tolvaptan Spray Dried Powder Manufacturer)@Otsuka Pharmaceutial Co., Ltd (Tolvaptan Manufacturer) (1)

04 Otsuka Pharmaceutical Co., Ltd (Tolvaptan Spray Dried Powder Manufacturer)@Otsuka Pharmaceutical Co., Ltd (Tolvaptan Manufacturer) (1)

05 Redox Bio Co., Ltd. (1)

06 Tyche Industries Limited (1)

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01 Aging Life Science Co., Ltd. (1)

02 Classia Co., Ltd. (1)

03 Jeil Pharmaceutical Co., Ltd. (1)

04 Korea Otsuka Pharmaceutical Co., Ltd. (2)

05 Redox Bio Co., Ltd. (1)

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01 Tolvaptan (4)

02 Tolvaptan SD powder (2)

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01 India (2)

02 Italy (1)

03 Japan (1)

04 South Korea (2)

URL Supplier Web Content
Jeil Pharmaceutical Co., Ltd.
2019-09-02
1668-23-ND
Jeil Pharmaceutical Co., ...
South Korea
7, Cheongganggachang-ro, ...
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Classia Co., Ltd.
2020-01-30
Number 758-3-ND
Lupin Ltd
India
T-142, Tarapur, Via Boisa...
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Korea Otsuka Pharmaceutical Co., Ltd.
2011-08-19
2662-2-ND
Otsuka Pharmaceutial Co.,...
Japan
463-10, Kagasuno, Kawauch...
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Korea Otsuka Pharmaceutical Co., Ltd.
2013-04-26
Number 1633-3-ND
Otsuka Pharmaceutical Co....
Japan
463-10, kagasuno, Kawauch...
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Redox Bio Co., Ltd.
2022-04-22
Number 357-1-ND
Redox Bio Co., Ltd.
South Korea
83, Jaekongdan 3-gil, Hya...
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Aging Life Science Co., Ltd.
2021-01-21
Number 434-28-ND
Tyche Industries Limited
India
D.No. 6-223, Sarpavaram, ...
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Looking for 150683-30-0 / Tolvaptan API manufacturers, exporters & distributors?

Tolvaptan manufacturers, exporters & distributors 1

48

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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Tolvaptan Drug Master File in Korea (Tolvaptan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tolvaptan. The MFDS reviews the Tolvaptan KDMF as part of the drug registration process and uses the information provided in the Tolvaptan KDMF to evaluate the safety and efficacy of the drug.

After submitting a Tolvaptan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tolvaptan API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tolvaptan suppliers with KDMF on PharmaCompass.

Tolvaptan Manufacturers | Traders | Suppliers

Tolvaptan Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Tolvaptan

Get in contact with the supplier of your choice:

  1. Jeil Pharmaceutical Co., Ltd
  2. Lupin Ltd
  3. Opocrin SpA
  4. Otsuka Pharmaceutical
  5. Redox Bio
  6. Tyche Industries Ltd
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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