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List of Drug Master Files (JDMF) for Cyclobenzaprine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Dipharma Francis S. r. l. (1)

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01 Cyclobenzaprine Hydrochloride (1)

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01 Italy (1)

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306MF10003
Via Bissone, 5, 20021-Baranzate, Mi...
2024-01-11
2024-01-11
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Looking for 6202-23-9 / Cyclobenzaprine API manufacturers, exporters & distributors?

Cyclobenzaprine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cyclobenzaprine

Synonyms

6202-23-9, Cyclobenzaprine hcl, Flexeril, Flexiban, Amrix, Lisseril

Cas Number

6202-23-9

Unique Ingredient Identifier (UNII)

0VE05JYS2P

About Cyclobenzaprine

Cyclobenzaprine Hydrochloride is a centrally acting muscle relaxant, chemically similar to amitriptyline hydrochloride with antidepressant activity. The exact mechanism of action of cyclobenzaprine hydrochloride has not been fully determined. However, it primarily acts at the brain stem to reduce tonic somatic motor activity, influencing both gamma and alpha motor neurons. This leads to a reduction in muscle spasms.

Cyclobenzaprine Manufacturers

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

Cyclobenzaprine Suppliers

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

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

Cyclobenzaprine 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 Cyclobenzaprine Drug Master File in Japan (Cyclobenzaprine JDMF) empowers Cyclobenzaprine 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 Cyclobenzaprine JDMF during the approval evaluation for pharmaceutical products. At the time of Cyclobenzaprine 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 Cyclobenzaprine suppliers with JDMF on PharmaCompass.

Cyclobenzaprine Manufacturers | Traders | Suppliers

Cyclobenzaprine Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Cyclobenzaprine

Get in contact with the supplier of your choice:

  1. Dipharma
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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