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01 1Fermion Oy
02 1ASG Biochem
03 1Cambrex Corporation
04 1Glenmark Life Sciences
05 1Guangzhou Tosun Pharmaceutical
06 1HONOUR LAB LTD
07 1Hangzhou Longshine Bio-Tech
08 1Hetero Drugs
09 1Maithri Drugs
10 1Olon S.p.A
11 1Shionogi
12 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 3China
02 1Finland
03 5India
04 1Italy
05 1Japan
06 1U.S.A
01 8Active
02 4Blank
01 12Blank
01 12Blank
01 1WC-0310
02 11Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25541
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-07
Pay. Date : 2016-09-07
DMF Number : 30858
Submission : 2016-10-17
Status : Active
Type : II
NDC Package Code : 69037-0026
Start Marketing Date : 2013-02-26
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 : 30574
Submission : 2016-06-30
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-912
Start Marketing Date : 2016-06-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35877
Submission : 2021-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30474
Submission : 2016-06-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38660
Submission : 2023-07-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-09-22
DMF Number : 29720
Submission : 2015-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31163
Submission : 2018-12-17
Status : Active
Type : II
A Osphena manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Osphena, including repackagers and relabelers. The FDA regulates Osphena manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Osphena 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 Osphena manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Osphena supplier is an individual or a company that provides Osphena active pharmaceutical ingredient (API) or Osphena finished formulations upon request. The Osphena suppliers may include Osphena API manufacturers, exporters, distributors and traders.
click here to find a list of Osphena suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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