Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Sanofi
03 1LGM Pharma
04 1Aspen API
05 1Nuray Chemicals Private Limited
06 1Symbiotec Pharmalab
07 1HRV Global Life Sciences
08 1AASraw Biochemical Technology Co., Ltd
09 1ASG Biochem
10 1Bayer AG
11 1Dr. Raju’s Pharma Solutions
12 1F. Hoffmann-La Roche
13 1Pfizer Inc
14 3Blank
01 1China
02 1France
03 2Germany
04 4India
05 1Netherlands
06 1Switzerland
07 3U.S.A
08 3Blank
01 3Active
02 7Inactive
03 6Blank
01 16Blank
01 16Blank
01 1WC-0416
02 15Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-09
Pay. Date : 2012-12-05
DMF Number : 25593
Submission : 2011-12-15
Status : Active
Type : II
NDC Package Code : 46439-8741
Start Marketing Date : 2011-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3775
Submission : 1980-04-15
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3861
Submission : 1980-05-21
Status : Active
Type : II
NDC Package Code : 60870-0232
Start Marketing Date : 1980-04-25
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 : 2020-01-24
Pay. Date : 2019-12-03
DMF Number : 34373
Submission : 2019-12-17
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 : 58159-070
Start Marketing Date : 2020-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : TW |
NDC Package Code : 22552-0020
Start Marketing Date : 2010-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3642
Submission : 1979-11-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4704
Submission : 1982-10-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2310
Submission : 1974-07-30
Status : Inactive
Type : II
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