Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
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01 1Noramco
02 2Veranova
03 1Rusan Pharma
04 1Alkem Laboratories
05 1Apotex Pharmachem
06 1Cambrex Corporation
07 1Centaur Pharmaceuticals
08 1Chattem Chemicals, Inc
09 2Curia
10 1Farmak JSC
11 1OmnisMed Pharmaceuticals
12 1SIGMA TAU
13 1Siegfried AG
14 1Tris Pharma Inc
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01 1Canada
02 3India
03 1Switzerland
04 9U.S.A
05 1Ukraine
06 1United Kingdom
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01 6Active
02 2Inactive
03 8Blank
01 16Blank
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01 16Blank
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01 1WC-0107
02 1WC-0278
03 1WC-0370n
04 13Blank
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01 16Blank
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01 10792-4356
02 117180-2010
03 149812-0207
04 159116-5950
05 161960-0221
06 165392-3417
07 10Blank
01 16Blank
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-28
Pay. Date : 2012-12-19
DMF Number : 24049
Submission : 2010-08-02
Status : Active
Type : II
NDC Package Code : 49812-0207
Start Marketing Date : 2010-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-25
Pay. Date : 2022-02-28
DMF Number : 36577
Submission : 2022-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33094
Submission : 2018-09-11
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-06
Pay. Date : 2022-08-17
DMF Number : 28289
Submission : 2014-06-19
Status : Active
Type : II
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0370n
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-28
Pay. Date : 2013-12-06
DMF Number : 27599
Submission : 2013-09-26
Status : Active
Type : II
NDC Package Code : 17180-2010
Start Marketing Date : 2002-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (13kg/13kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-31
Pay. Date : 2022-05-17
DMF Number : 35870
Submission : 2022-04-25
Status : Active
Type : II
NDC Package Code : 59116-5950
Start Marketing Date : 2021-12-14
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 : 3274
Submission : 1978-07-31
Status : Inactive
Type : II
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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.
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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.
We have 14 companies offering Sodium Oxybate
Get in contact with the supplier of your choice: