01 1Gedeon Richter
02 1Syn-Tech Chem. & Pharm
01 1TOLPERISONE HCl
02 1TOLPERISONE HYDROCHLORIDE
01 1Hungary
02 1Taiwan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5590
Submission : 1984-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25466
Submission : 2011-10-31
Status : Active
Type : II
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PharmaCompass offers a list of Tolperisone 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 Tolperisone manufacturer or Tolperisone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tolperisone manufacturer or Tolperisone supplier.
PharmaCompass also assists you with knowing the Tolperisone API Price utilized in the formulation of products. Tolperisone API Price is not always fixed or binding as the Tolperisone Price is obtained through a variety of data sources. The Tolperisone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tolperisone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolperisone, including repackagers and relabelers. The FDA regulates Tolperisone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolperisone 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 Tolperisone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolperisone supplier is an individual or a company that provides Tolperisone active pharmaceutical ingredient (API) or Tolperisone finished formulations upon request. The Tolperisone suppliers may include Tolperisone API manufacturers, exporters, distributors and traders.
click here to find a list of Tolperisone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolperisone DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolperisone active pharmaceutical ingredient (API) in detail. Different forms of Tolperisone DMFs exist exist since differing nations have different regulations, such as Tolperisone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolperisone DMF submitted to regulatory agencies in the US is known as a USDMF. Tolperisone USDMF includes data on Tolperisone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolperisone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolperisone suppliers with USDMF on PharmaCompass.
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