Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Gonane Pharma
03 1EUROAPI
04 1Sanofi
05 1Aspen API
06 1Fareva
07 1Hubei Gedian Humanwell Pharmaceutical
08 1AASraw Biochemical Technology Co., Ltd
09 1ASG Biochem
10 1Balaji Corporation
11 1Bayer AG
12 1Fujifilm Diosynth Biotechnologies
13 1Gedeon Richter
14 1Hangzhou Deli Chemical
15 1Ipca Laboratories
16 1Lupin Ltd
17 1Steroid SpA
18 1Swati Spentose
19 1Zhejiang Xianju Pharmaceutical Co. Ltd
20 1Blank
01 4China
02 2France
03 1Germany
04 1Hungary
05 7India
06 1Italy
07 1Luxembourg
08 1Netherlands
09 1United Kingdom
10 1Blank
01 4Active
02 3Inactive
03 13Blank
01 3Valid
02 17Blank
01 1303MF10163
02 19Blank
01 1WC-0402A2
02 19Blank
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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 : 3072
Submission : 1977-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-06
Pay. Date : 2014-12-22
DMF Number : 12268
Submission : 1996-12-16
Status : Active
Type : II
Certificate Number : R1-CEP 2009-171 - Rev 01
Issue Date : 2016-07-15
Type : Chemical
Substance Number : 1614
Status : Valid
NDC Package Code : 60870-0276
Start Marketing Date : 1980-04-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Sinex Co., Ltd.
Registration Date : 2022-05-26
Registration Number : 20220526-181-I-638-07
Manufacturer Name : Aspen Oss BV@Aspen Oss BV
Manufacturer Address : Kloosterstraat 6, Oss, 5349 AB, The Netherlands@Veersemeer 4, Oss, 5347 JN, The Netherlands
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-02
Pay. Date : 2017-04-04
DMF Number : 23948
Submission : 2010-07-02
Status : Active
Type : II
Registration Number : 303MF10163
Registrant's Address : Parc Industriel d'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex France
Initial Date of Registration : 2021-11-10
Latest Date of Registration : --
NDC Package Code : 24823-905
Start Marketing Date : 2010-02-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39594
Submission : 2024-03-20
Status : Active
Type : II
NDC Package Code : 49803-013
Start Marketing Date : 2024-02-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25000g/25000g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24553
Submission : 2011-01-18
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 : 4267
Submission : 1981-09-03
Status : Inactive
Type : II
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