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

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01 Gedeon Richter (1)

02 Syn-Tech Chem. & Pharm (1)

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01 TOLPERISONE HCl (1)

02 TOLPERISONE HYDROCHLORIDE (1)

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01 Hungary (1)

02 Taiwan (1)

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01 Active (1)

02 Inactive (1)

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01 Blank (2)

URL Supplier Web Content
5590
Inactive
1984-10-24
N/A
II
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URL Supplier Web Content
25466
Active
2011-10-31
N/A
II
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Looking for 3644-61-9 / Tolperisone API manufacturers, exporters & distributors?

Tolperisone manufacturers, exporters & distributors 1

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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.

API | Excipient name

Tolperisone

Synonyms

3644-61-9, Tolperisone hcl, Midocalm, Muscalm, Tolperisone (hydrochloride), 2,4'-dimethyl-3-piperidinopropiophenone hydrochloride

Cas Number

3644-61-9

Unique Ingredient Identifier (UNII)

8Z075K2TIG

About Tolperisone

A centrally acting muscle relaxant that has been used for the symptomatic treatment of spasticity and muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1211)

Tolperisone Manufacturers

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.

Tolperisone Suppliers

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.

Tolperisone USDMF

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.

Tolperisone Manufacturers | Traders | Suppliers

Tolperisone Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Tolperisone

Get in contact with the supplier of your choice:

  1. Gedeon Richter
  2. Syn-Tech Chem. & Pharm
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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