Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Nuray Chemicals Private Limited
03 1Gonane Pharma
04 1HRV Global Life Sciences
05 1TAPI Technology & API Services
06 1Curia
07 1Guangzhou Topwork Chemical
08 1Henan Lihua Pharmaceutical
09 1Pfizer Inc
10 1Teva Pharmaceutical Industries
11 1Viatris
01 2China
02 1Germany
03 3India
04 2Israel
05 3U.S.A
01 5Active
02 1Inactive
03 5Blank
01 1Expired
02 2Valid
03 8Blank
01 11Blank
01 1WC-0416
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14136
Submission : 1999-05-12
Status : Active
Type : II
Certificate Number : R0-CEP 2019-084 - Rev 00
Issue Date : 2020-11-18
Type : Chemical
Substance Number : 767
Status : Valid
NDC Package Code : 46439-8721
Start Marketing Date : 1999-05-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2021-12-02
Registration Number : 20211202-209-J-1149
Manufacturer Name : Farmabios SPA@MICROCHEM SRL
Manufacturer Address : Via Pavia 1 - 27027 Gropello Cairoli (PV), Italy@Via Turati, 2 - 29017 Fiorenzuola d'Arda (PC) Italy
Available Reg Filing : EU |
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 : 2020-06-17
Pay. Date : 2020-06-08
DMF Number : 34923
Submission : 2020-06-09
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 : 58159-074
Start Marketing Date : 2020-02-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14703
Submission : 1999-12-20
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36367
Submission : 2021-11-11
Status : Active
Type : II
Certificate Number : CEP 2021-435 - Rev 00
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 767
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22994
Submission : 2009-07-27
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-324 - Rev 00
Issue Date : 2002-04-09
Type : TSE
Substance Number : 767
Status : Expired
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