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GDUFA

DMF Review : Complete

Rev. Date : 2022-03-29

Pay. Date : 2022-03-09

DMF Number : 36167

Submission : 2021-09-30

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2022-10-18

Pay. Date : 2022-07-14

DMF Number : 37079

Submission : 2022-07-15

Status : Active

Type : II

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

Metaxalone manufacturers, exporters & distributors 1

16

PharmaCompass offers a list of Metaxalone 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 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.

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

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.

FS-3218 Manufacturers

A FS-3218 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FS-3218, including repackagers and relabelers. The FDA regulates FS-3218 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FS-3218 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 FS-3218 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

FS-3218 Suppliers

A FS-3218 supplier is an individual or a company that provides FS-3218 active pharmaceutical ingredient (API) or FS-3218 finished formulations upon request. The FS-3218 suppliers may include FS-3218 API manufacturers, exporters, distributors and traders.

click here to find a list of FS-3218 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

FS-3218 USDMF

A FS-3218 DMF (Drug Master File) is a document detailing the whole manufacturing process of FS-3218 active pharmaceutical ingredient (API) in detail. Different forms of FS-3218 DMFs exist exist since differing nations have different regulations, such as FS-3218 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A FS-3218 DMF submitted to regulatory agencies in the US is known as a USDMF. FS-3218 USDMF includes data on FS-3218's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FS-3218 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of FS-3218 suppliers with USDMF on PharmaCompass.

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.