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List of Drug Master Files (DMF) of Tolvaptan Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Extrovis AG (1)

02 Alkem Laboratories (1)

03 Apotex Pharmachem (1)

04 Aurore Life Sciences (2)

05 Hetero Drugs (1)

06 Jiangsu Hengrui Medicine (1)

07 Lupin Ltd (1)

08 MSN Laboratories (2)

09 Olon S.p.A (1)

10 Zhejiang Huahai Pharmaceutical (1)

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01 TOLVAPTAN (9)

02 TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA] (1)

03 TOLVAPTAN AMORPHOUS (1)

04 TOLVAPTAN [ROUTE CODE "TN"] (1)

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01 Canada (1)

02 China (2)

03 India (7)

04 Italy (1)

05 Switzerland (1)

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01 Active (12)

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01 Complete (7)

02 Blank (5)

34316
Active
2020-01-22
N/A
II
Extrovis Company Banner

Cophex 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
32030
Active
2017-10-06
Complete
2017-11-15
2017-10-12
II
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URL Supplier Web Content
27636
Active
2013-12-04
Complete
2014-04-11
2013-11-14
II
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URL Supplier Web Content
27052
Active
2013-04-03
Complete
2013-11-05
2013-04-26
II
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URL Supplier Web Content
27833
Active
2014-01-13
Complete
2014-06-06
2014-02-26
II
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URL Supplier Web Content
32623
Active
2019-05-03
Complete
2019-06-18
2019-05-10
II
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URL Supplier Web Content
28010
Active
2014-02-26
Complete
2019-12-30
2019-12-10
II
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URL Supplier Web Content
27808
Active
2013-12-28
N/A
II
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URL Supplier Web Content
32717
Active
2018-05-16
N/A
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URL Supplier Web Content
27132
Active
2013-05-22
Complete
2013-11-12
2013-05-24
II
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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 USDMF

A Tolvaptan DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolvaptan active pharmaceutical ingredient (API) in detail. Different forms of Tolvaptan DMFs exist exist since differing nations have different regulations, such as Tolvaptan USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tolvaptan DMF submitted to regulatory agencies in the US is known as a USDMF. Tolvaptan USDMF includes data on Tolvaptan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolvaptan USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Tolvaptan suppliers with USDMF 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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