Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1Apotex Pharmachem
03 1Everlight Chemical
04 2MSN Laboratories
05 1TIEN (Tianjin) Pharmaceutical
01 2TREPROSTINIL DIETHANOLAMINE
02 1TREPROSTINIL DIETHANOLAMINE (CRYSTALLINE) [ROUTE CODE "VM"]
03 1TREPROSTINIL DIETHANOLAMINE [ROUTE CODE TB]
04 2TREPROSTINIL DIOLAMINE
01 1Canada
02 1China
03 3India
04 1Taiwan
01 6Active
01 4Complete
02 2Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-02-13
DMF Number : 31385
Submission : 2017-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-09
Pay. Date : 2017-09-27
DMF Number : 32086
Submission : 2017-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-18
Pay. Date : 2016-06-16
DMF Number : 30535
Submission : 2016-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30314
Submission : 2016-02-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-08
Pay. Date : 2015-12-14
DMF Number : 30000
Submission : 2015-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31524
Submission : 2017-12-06
Status : Active
Type : II
A Treprostinil Diolamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Treprostinil Diolamine, including repackagers and relabelers. The FDA regulates Treprostinil Diolamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Treprostinil Diolamine 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 Treprostinil Diolamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Treprostinil Diolamine supplier is an individual or a company that provides Treprostinil Diolamine active pharmaceutical ingredient (API) or Treprostinil Diolamine finished formulations upon request. The Treprostinil Diolamine suppliers may include Treprostinil Diolamine API manufacturers, exporters, distributors and traders.
click here to find a list of Treprostinil Diolamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Treprostinil Diolamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Treprostinil Diolamine active pharmaceutical ingredient (API) in detail. Different forms of Treprostinil Diolamine DMFs exist exist since differing nations have different regulations, such as Treprostinil Diolamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Treprostinil Diolamine DMF submitted to regulatory agencies in the US is known as a USDMF. Treprostinil Diolamine USDMF includes data on Treprostinil Diolamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Treprostinil Diolamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Treprostinil Diolamine suppliers with USDMF on PharmaCompass.
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