Chirogate is a professional Prostaglandin manufacturer.
01 3Chirogate International
02 1Nuray Chemicals Private Limited
03 1ChemWerth Inc
04 1EUROAPI
05 1LGM Pharma
06 1Dr. Reddy's Laboratories
07 1HRV Global Life Sciences
08 1Alphora Research
09 1DMFs Not Supported
10 1Emcure Pharmaceuticals
11 1Hetero Drugs
12 2MSN Laboratories
13 1Mannkind
14 1Mehta API
15 1Pfizer Inc
16 1Shanghai Hope Chem
17 1Yonsung Fine Chemicals
18 1Zhejiang Ausun Pharmaceutical
01 1Canada
02 2China
03 1France
04 8India
05 1South Korea
06 3Taiwan
07 4U.S.A
08 1Blank
01 13Active
02 1Inactive
03 7Blank
01 21Blank
01 21Blank
01 1WC-0214
02 1WC-0416
03 19Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28340
Submission : 2016-08-15
Status : Active
Type : II
NDC Package Code : 68245-0008
Start Marketing Date : 2010-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-16
Pay. Date : 2016-09-20
DMF Number : 30861
Submission : 2016-09-27
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-040
Start Marketing Date : 2016-06-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-23
Pay. Date : 2016-11-25
DMF Number : 31145
Submission : 2016-12-09
Status : Active
Type : II
NDC Package Code : 82231-115
Start Marketing Date : 2019-11-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-06
Pay. Date : 2016-06-10
DMF Number : 30106
Submission : 2016-01-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-06
Pay. Date : 2014-07-15
DMF Number : 28458
Submission : 2014-09-16
Status : Active
Type : II
NDC Package Code : 68245-0008
Start Marketing Date : 2010-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29207
Submission : 2015-08-12
Status : Active
Type : II
NDC Package Code : 68245-0008
Start Marketing Date : 2010-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31450
Submission : 2017-02-28
Status : Active
Type : II
NDC Package Code : 14501-0015
Start Marketing Date : 2014-08-25
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 : 31573
Submission : 2017-03-30
Status : Active
Type : II
NDC Package Code : 14501-0015
Start Marketing Date : 2014-08-25
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 : 33169
Submission : 2018-10-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-24
Pay. Date : 2018-09-19
DMF Number : 32992
Submission : 2018-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25548
Submission : 2011-12-01
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-06
Pay. Date : 2021-09-28
DMF Number : 34786
Submission : 2021-01-16
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-04
Pay. Date : 2013-11-20
DMF Number : 27680
Submission : 2013-10-16
Status : Active
Type : II
NDC Package Code : 40016-009
Start Marketing Date : 2012-05-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6804
Submission : 1987-02-02
Status : Inactive
Type : II
Date of Issue : 2020-02-14
Valid Till : 2022-07-02
Written Confirmation Number : WC-0214
Address of the Firm :
A Treprostinil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Treprostinil, including repackagers and relabelers. The FDA regulates Treprostinil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Treprostinil 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Treprostinil supplier is an individual or a company that provides Treprostinil active pharmaceutical ingredient (API) or Treprostinil finished formulations upon request. The Treprostinil suppliers may include Treprostinil API manufacturers, exporters, distributors and traders.
click here to find a list of Treprostinil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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