Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 1LGM Pharma
03 1Aspen API
04 1Gonane Pharma
05 1HRV Global Life Sciences
06 1ACS DOBFAR SPA
07 1ASG Biochem
08 1Balaji Corporation
09 1Bayer AG
10 2Fujifilm Diosynth Biotechnologies
11 1Hangzhou Think Chemical Co.Ltd
12 1Mortar & Pestle
13 1Naari
14 2Pfizer Inc
15 1Steroid SpA
16 1Sun Pharmaceutical Industries Limited
17 1VM Life Science
01 1China
02 1Germany
03 10India
04 2Italy
05 1Netherlands
06 3U.S.A
07 2United Kingdom
01 4Active
02 6Inactive
03 10Blank
01 20Blank
01 20Blank
01 1WC-0161A2
02 1WC-0162
03 1WC-0168
04 17Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-16
Pay. Date : 2017-01-30
DMF Number : 30747
Submission : 2016-07-19
Status : Active
Type : II
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0045
Start Marketing Date : 2016-03-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2017-01-09
DMF Number : 17113
Submission : 2004-01-21
Status : Active
Type : II
NDC Package Code : 60870-0408
Start Marketing Date : 1992-01-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0045
Start Marketing Date : 2016-03-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-18
Pay. Date : 2017-04-11
DMF Number : 31337
Submission : 2017-01-18
Status : Active
Type : II
NDC Package Code : 49803-001
Start Marketing Date : 2015-09-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25000g/25000g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-20
Pay. Date : 2015-01-02
DMF Number : 28958
Submission : 2015-02-06
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
NDC Package Code : 62756-303
Start Marketing Date : 2020-05-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
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 : 2993
Submission : 1977-07-18
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 : 3845
Submission : 1980-05-21
Status : Inactive
Type : II
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