Veranova: A CDMO that manages complexity with confidence.
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01 2Veranova
02 1Alkem Laboratories
03 1Apotex Pharmachem
04 1Cambrex Corporation
05 1Curia
06 1SIGMA TAU
07 1Tris Pharma Inc
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01 1CATABATE, SODIUM OXYBATE, GAMMA-HYDROXYBUTYRIC ACID, SODIUM SALT
02 1GAMMA-HYDROXYBUTYRATE
03 1OXYBATE EXTENDED-RELEASE POWDER FOR ORAL SUSPENSION (OXYBATE ER POS)
04 4SODIUM OXYBATE
05 1SODIUM OXYBATE AQUEOUS CONCENTRATE
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01 1Canada
02 1India
03 6U.S.A
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01 6Active
02 2Inactive
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01 5Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2012-12-19
DMF Number : 24049
Submission : 2010-08-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-25
Pay. Date : 2022-02-28
DMF Number : 36577
Submission : 2022-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-06
Pay. Date : 2022-08-17
DMF Number : 28289
Submission : 2014-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7249
Submission : 1987-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-31
Pay. Date : 2022-05-17
DMF Number : 35870
Submission : 2022-04-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-28
Pay. Date : 2013-12-06
DMF Number : 27599
Submission : 2013-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3274
Submission : 1978-07-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33094
Submission : 2018-09-11
Status : Active
Type : II
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PharmaCompass offers a list of Gamma-Hydroxybutyric Acid Sodium 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 Gamma-Hydroxybutyric Acid Sodium manufacturer or Gamma-Hydroxybutyric Acid Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gamma-Hydroxybutyric Acid Sodium manufacturer or Gamma-Hydroxybutyric Acid Sodium supplier.
PharmaCompass also assists you with knowing the Gamma-Hydroxybutyric Acid Sodium API Price utilized in the formulation of products. Gamma-Hydroxybutyric Acid Sodium API Price is not always fixed or binding as the Gamma-Hydroxybutyric Acid Sodium Price is obtained through a variety of data sources. The Gamma-Hydroxybutyric Acid Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium Oxybate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Oxybate, including repackagers and relabelers. The FDA regulates Sodium Oxybate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Oxybate 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 Sodium Oxybate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Oxybate supplier is an individual or a company that provides Sodium Oxybate active pharmaceutical ingredient (API) or Sodium Oxybate finished formulations upon request. The Sodium Oxybate suppliers may include Sodium Oxybate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Oxybate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Oxybate DMFs exist exist since differing nations have different regulations, such as Sodium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Oxybate USDMF includes data on Sodium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Oxybate suppliers with USDMF on PharmaCompass.
We have 7 companies offering Sodium Oxybate
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