Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Gonane Pharma
03 1EUROAPI
04 1Sanofi
05 1Transo-Pharm Handels GmbH
06 1Aspen API
07 1Fareva
08 1Hubei Gedian Humanwell Pharmaceutical
09 1AASraw Biochemical Technology Co., Ltd
10 1ASG Biochem
11 1Balaji Corporation
12 1Bayer AG
13 1Fujifilm Diosynth Biotechnologies
14 1Gedeon Richter
15 1Hangzhou Deli Chemical
16 1Ipca Laboratories
17 1Lupin Ltd
18 1Shakti Lifescience
19 1Steroid SpA
20 1Swati Spentose
21 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 4China
02 2France
03 2Germany
04 1Hungary
05 8India
06 1Italy
07 1Luxembourg
08 1Netherlands
09 1United Kingdom
01 4Active
02 3Inactive
03 14Blank
01 4Valid
02 17Blank
01 1303MF10163
02 20Blank
01 1WC-0402A2
02 20Blank
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
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
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 : Synex 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
Certificate Number : CEP 2010-224 - Rev 05
Issue Date : 2024-06-20
Type : Chemical
Substance Number : 1614
Status : Valid
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
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