With Fermion, start the journey of your innovative API.
01 1Fermion Oy
02 1Cambrex Corporation
03 1Glenmark Life Sciences
04 1HONOUR LAB LTD
05 1Maithri Drugs
06 1Olon S.p.A
07 1Shionogi
08 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 8OSPEMIFENE
01 1China
02 1Finland
03 3India
04 1Italy
05 1Japan
06 1U.S.A
01 8Active
01 2Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25541
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31163
Submission : 2018-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30574
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-07
Pay. Date : 2016-09-07
DMF Number : 30858
Submission : 2016-10-17
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 : Complete
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 : 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
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.
A Osphena DMF (Drug Master File) is a document detailing the whole manufacturing process of Osphena active pharmaceutical ingredient (API) in detail. Different forms of Osphena DMFs exist exist since differing nations have different regulations, such as Osphena USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Osphena DMF submitted to regulatory agencies in the US is known as a USDMF. Osphena USDMF includes data on Osphena's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Osphena USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Osphena suppliers with USDMF on PharmaCompass.
We have 8 companies offering Osphena
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?