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List of Japan Drug Master File (JDMF) for Tizanidine HCl Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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227MF10142
Na vlcinci 16/3 Klasterni Hradisko ...
2022-06-15
2015-05-20
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303MF10146
2-36-1 Kanda Jimbocho, Chiyoda-ku, ...
2021-09-09
2021-09-09
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2023-01-18
2023-01-18
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1-10-11 Nihonbashi Horidome-cho, Ch...
2010-02-16
2005-10-07
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1410 Takada, Kashiwa City, Chiba Pr...
2010-02-22
2010-02-22
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  • TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 4MG BASE
  • CAPSULE;ORAL - EQ 2MG BASE
  • CAPSULE;ORAL - EQ 4MG BASE
  • CAPSULE;ORAL - EQ 6MG BASE

Looking for 64461-82-1 / Tizanidine HCl API manufacturers, exporters & distributors?

Tizanidine HCl manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tizanidine HCl

Synonyms

64461-82-1, Zanaflex, Tizanidine (hydrochloride), 5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride, Ds 103-282, An021

Cas Number

64461-82-1

Unique Ingredient Identifier (UNII)

B53E3NMY5C

About Tizanidine HCl

Tizanidine Hydrochloride is the hydrochloride salt form of tizanidine, an imidazoline derivative structurally similar to clonidine and an adrenergic agonist with muscle relaxant property. Tizanidine stimulates alpha-2 adrenergic receptors in the central nervous system, thereby inhibiting presynaptic release of norepinephrine and increasing the inhibitory effect on alpha motor neurons and motor reflexes. Tizanidine exerts some activity at the postsynaptic excitatory amino acid receptors and imidazoline receptors which may contribute to the overall reduction in facilitation of spinal motor neurons. Overall, tizanidine hydrochloride causes muscle relaxation, reduces spasticity and antinociceptive effects.

Tizanidine HCl Manufacturers

A Tizanidine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tizanidine HCl, including repackagers and relabelers. The FDA regulates Tizanidine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tizanidine HCl 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 Tizanidine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tizanidine HCl Suppliers

A Tizanidine HCl supplier is an individual or a company that provides Tizanidine HCl active pharmaceutical ingredient (API) or Tizanidine HCl finished formulations upon request. The Tizanidine HCl suppliers may include Tizanidine HCl API manufacturers, exporters, distributors and traders.

click here to find a list of Tizanidine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tizanidine HCl JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Tizanidine HCl Drug Master File in Japan (Tizanidine HCl JDMF) empowers Tizanidine HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Tizanidine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Tizanidine HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Tizanidine HCl suppliers with JDMF on PharmaCompass.

Tizanidine HCl Manufacturers | Traders | Suppliers

Tizanidine HCl Manufacturers, Traders, Suppliers 1
25

We have 6 companies offering Tizanidine HCl

Get in contact with the supplier of your choice:

  1. FARMAK, a.s
  2. Active Pharma
  3. Permachem
  4. Permachem Asia, Ltd
  5. Ryoto Fine Co
  6. Sagami Chemical Industry
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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