Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 1Aspen API
03 1Sichuan Elixir Pharmaceuticals
04 1Dr. Raju’s Pharma Solutions
05 2Merck & Co
06 1Perrigo Company plc
07 1Plantex Ltd.
08 3TAPI Technology & API Services
09 1Wyeth Pharmaceuticals Inc
10 2XINJIANG NUZILINE BIO PHARMACEUTICAL CO LTD
11 2Blank
01 3China
02 2India
03 1Ireland
04 4Israel
05 1Netherlands
06 4U.S.A
07 2Blank
01 4Active
02 10Inactive
03 3Blank
01 1Valid
02 16Blank
01 17Blank
01 1WC-0161A2
02 1WC-0162
03 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27920
Submission : 2014-02-19
Status : Active
Type : II
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0017
Start Marketing Date : 2010-05-11
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 : 34883
Submission : 2020-06-09
Status : Active
Type : II
NDC Package Code : 60870-0422
Start Marketing Date : 1995-07-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0017
Start Marketing Date : 2010-05-11
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 : 14046
Submission : 1999-03-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-09
Pay. Date : 2015-09-29
DMF Number : 29827
Submission : 2015-09-18
Status : Active
Type : II
NDC Package Code : 70203-101
Start Marketing Date : 2015-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (80mg/80mg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3011
Submission : 1977-08-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25337
Submission : 2011-09-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-153 - Rev 00
Issue Date : 2018-02-19
Type : Chemical
Substance Number : 1512
Status : Valid
NDC Package Code : 70203-101
Start Marketing Date : 2015-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (80mg/80mg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 934
Submission : 1965-12-08
Status : Inactive
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 7328
Submission : 1988-02-09
Status : Inactive
Type : II
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