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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

GDUFA

DMF Review : Complete

Rev. Date : 2015-04-03

Pay. Date : 2013-05-21

DMF Number : 20581

Submission : 2007-06-06

Status : Active

Type : II

Polpharma CB

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Looking for 97240-79-4 / Topiramate API manufacturers, exporters & distributors?

Topiramate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Topiramate

Synonyms

97240-79-4, Topamax, Epitomax, Topamax sprinkle, Topina, Mcn-4853

Cas Number

97240-79-4

Unique Ingredient Identifier (UNII)

0H73WJJ391

About Topiramate

A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate Manufacturers

A [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate, including repackagers and relabelers. The FDA regulates [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate 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 [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate Suppliers

A [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate supplier is an individual or a company that provides [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate active pharmaceutical ingredient (API) or [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate finished formulations upon request. The [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate suppliers may include [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate API manufacturers, exporters, distributors and traders.

click here to find a list of [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate USDMF

A [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate DMF (Drug Master File) is a document detailing the whole manufacturing process of [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate active pharmaceutical ingredient (API) in detail. Different forms of [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate DMFs exist exist since differing nations have different regulations, such as [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate DMF submitted to regulatory agencies in the US is known as a USDMF. [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate USDMF includes data on [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate suppliers with USDMF on PharmaCompass.

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate Manufacturers | Traders | Suppliers

[(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0?,?]dodecan-6-yl]methyl sulfamate 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.