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 1Changzhou BOHIV Pharmaceutical
10 1DMFs Not Supported
11 1Emcure Pharmaceuticals
12 1Hetero Drugs
13 2MSN Laboratories
14 1Mannkind
15 1Mehta API
16 1Pfizer Inc
17 1Shanghai Hope Chem
18 1Yonsung Fine Chemicals
19 1Zhejiang Ausun Pharmaceutical
01 1Canada
02 3China
03 1France
04 8India
05 1South Korea
06 3Taiwan
07 4U.S.A
08 1Blank
01 14Active
02 1Inactive
03 7Blank
01 22Blank
01 22Blank
01 1WC-0214
02 1WC-0416
03 20Blank
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33169
Submission : 2018-10-17
Status : Active
Type : II
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