Chirogate is a professional Prostaglandin manufacturer.
01 3Chirogate International
02 1Nuray Chemicals Private Limited
03 1EUROAPI
04 1Dr. Reddy's Laboratories
05 1Alphora Research
06 1DMFs Not Supported
07 1Emcure Pharmaceuticals
08 2MSN Laboratories
09 1Mannkind
10 1Pfizer Inc
11 1Yonsung Fine Chemicals
01 1HEXADECYL TREPROSTINIL
02 4TREPROSTINIL
03 1TREPROSTINIL INHALATION POWDER
04 6TREPROSTINIL SODIUM
05 1TREPROSTINIL SODIUM 5.5 HYDRATE
06 1U-62,840
01 1Canada
02 1France
03 5India
04 1South Korea
05 3Taiwan
06 2U.S.A
07 1Blank
01 13Active
02 1Inactive
01 7Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28340
Submission : 2016-08-15
Status : Active
Type : II
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 : 2017-02-16
Pay. Date : 2016-09-20
DMF Number : 30861
Submission : 2016-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-11-25
DMF Number : 31145
Submission : 2016-12-09
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-06-10
DMF Number : 30106
Submission : 2016-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29207
Submission : 2015-08-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-07-15
DMF Number : 28458
Submission : 2014-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25548
Submission : 2011-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31573
Submission : 2017-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31450
Submission : 2017-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-04
Pay. Date : 2013-11-20
DMF Number : 27680
Submission : 2013-10-16
Status : Active
Type : II
A Treprostinil Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Treprostinil Sodium, including repackagers and relabelers. The FDA regulates Treprostinil Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Treprostinil Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Treprostinil Sodium supplier is an individual or a company that provides Treprostinil Sodium active pharmaceutical ingredient (API) or Treprostinil Sodium finished formulations upon request. The Treprostinil Sodium suppliers may include Treprostinil Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Treprostinil Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Treprostinil Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Treprostinil Sodium active pharmaceutical ingredient (API) in detail. Different forms of Treprostinil Sodium DMFs exist exist since differing nations have different regulations, such as Treprostinil Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Treprostinil Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Treprostinil Sodium USDMF includes data on Treprostinil Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Treprostinil Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Treprostinil Sodium suppliers with USDMF on PharmaCompass.
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