Aspen API. More than just an API.
01 1Aspen API
02 1Curia
03 1Gedeon Richter
04 1Industriale Chimica
05 1Sterling Spa
06 1Steroid SpA
01 6ETONOGESTREL
01 1Hungary
02 3Italy
03 1Netherlands
04 1U.S.A
01 6Active
01 4Complete
02 2Blank
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12293
Submission : 1996-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-02
Pay. Date : 2017-12-20
DMF Number : 32271
Submission : 2017-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-22
Pay. Date : 2014-03-26
DMF Number : 11997
Submission : 1996-06-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-12
Pay. Date : 2015-04-02
DMF Number : 29165
Submission : 2015-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-05
DMF Number : 24651
Submission : 2011-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39455
Submission : 2024-02-28
Status : Active
Type : II
A Nexplanon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexplanon, including repackagers and relabelers. The FDA regulates Nexplanon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexplanon 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 Nexplanon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexplanon supplier is an individual or a company that provides Nexplanon active pharmaceutical ingredient (API) or Nexplanon finished formulations upon request. The Nexplanon suppliers may include Nexplanon API manufacturers, exporters, distributors and traders.
click here to find a list of Nexplanon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nexplanon DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexplanon active pharmaceutical ingredient (API) in detail. Different forms of Nexplanon DMFs exist exist since differing nations have different regulations, such as Nexplanon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexplanon DMF submitted to regulatory agencies in the US is known as a USDMF. Nexplanon USDMF includes data on Nexplanon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexplanon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexplanon suppliers with USDMF on PharmaCompass.
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