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GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-29
Pay. Date : 2022-03-09
DMF Number : 36167
Submission : 2021-09-30
Status : Active
Type : II
Date of Issue : 2023-10-25
Valid Till : 2026-01-07
Written Confirmation Number : WC-471
Address of the Firm :

GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-08-01
DMF Number : 25533
Submission : 2011-11-21
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-18
Pay. Date : 2022-07-14
DMF Number : 37079
Submission : 2022-07-15
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-06-03
Pay. Date : 2025-05-29
DMF Number : 23980
Submission : 2010-07-19
Status : Active
Type : II
NDC Package Code : 47621-020
Start Marketing Date : 2013-06-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27105
Submission : 2013-04-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24409
Submission : 2010-11-22
Status : Inactive
Type : II
NDC Package Code : 12666-0012
Start Marketing Date : 2010-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14395
Submission : 1999-09-08
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5435
Submission : 1984-06-28
Status : Inactive
Type : II

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.
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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.
A Skelaxin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Skelaxin, including repackagers and relabelers. The FDA regulates Skelaxin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Skelaxin 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 Skelaxin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Skelaxin supplier is an individual or a company that provides Skelaxin active pharmaceutical ingredient (API) or Skelaxin finished formulations upon request. The Skelaxin suppliers may include Skelaxin API manufacturers, exporters, distributors and traders.
click here to find a list of Skelaxin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 23 companies offering Skelaxin
Get in contact with the supplier of your choice: