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GDUFA

DMF Review : Complete

Rev. Date : 2022-03-29

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DMF Number : 36167

Submission : 2021-09-30

Status : Active

Type : II

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Looking for 1665-48-1 / Metaxalone API manufacturers, exporters & distributors?

Metaxalone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Metaxalone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Metaxalone manufacturer or Metaxalone supplier for your needs.

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

API | Excipient name

Metaxalone

Synonyms

1665-48-1, Skelaxin, Zorane, Methaxalonum, Metaxalon, Methoxolone

Cas Number

1665-48-1

Unique Ingredient Identifier (UNII)

1NMA9J598Y

About Metaxalone

Metaxalone is an oxazolidinone with centrally-acting skeletal muscle relaxant properties. Although the exact mechanism through which metaxalone exerts its effect is largely unknown, it might be due to general central nervous system (CNS) depression. Metaxalone has no direct effect on the contractile mechanisms of striated muscle, the motor end plate, or the nerve fiber.

Metazolone Manufacturers

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

Metazolone Suppliers

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

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

Metazolone USDMF

A Metazolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Metazolone active pharmaceutical ingredient (API) in detail. Different forms of Metazolone DMFs exist exist since differing nations have different regulations, such as Metazolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Metazolone DMF submitted to regulatory agencies in the US is known as a USDMF. Metazolone USDMF includes data on Metazolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Metazolone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Metazolone suppliers with USDMF on PharmaCompass.

Metazolone Manufacturers | Traders | Suppliers

Metazolone 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.