Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 3Symbiotec Pharmalab
02 1Gonane Pharma
03 1Axplora
04 3EUROAPI
05 1Transo-Pharm USA LLC
06 1Aspen API
07 1Hubei Gedian Humanwell Pharmaceutical
08 1Atman Pharmaceuticals
09 1Anuh Pharma LTD
10 1Arudavis Labs
11 1Aurisco Pharmaceutical
12 2Bayer AG
13 1Biotechnica DWC
14 1DMFs Not Supported
15 3Fujifilm Diosynth Biotechnologies
16 3Henan Lihua Pharmaceutical
17 1Hengdian Group
18 1Hunan Yuxin Pharmaceutical Co., Ltd.
19 1JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTD
20 1Laboratorio Syntex S.A
21 1Mahima Life Sciences
22 1Medimpex
23 1NEWCHEM SPA
24 1Nanjing Dorra Pharmaceutical Technology Co.,Ltd
25 1Olon S.p.A
26 1Otto Brandes
27 2Pfizer Inc
28 1Qingdao Qingmei Biotech
29 1Roussel Delma Pharmaceuticals
30 2Shandong Xinhua Pharmaceutical
31 1Steroid SpA
32 2Symbiotica Specialty Ingredients
33 1Teva API
34 1Tianjin Pharmaceutical Holdings Ltd
35 2Tianjin Tianyao Pharmaceuticals Co., Ltd.
36 1Unimax Group
37 2Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Algeria
02 1Argentina
03 17China
04 3France
05 4Germany
06 9India
07 1Israel
08 3Italy
09 2Malaysia
10 1Netherlands
11 4U.S.A
12 4United Kingdom
13 1Blank
01 11Active
02 11Inactive
03 29Blank
01 2Expired
02 12Valid
03 1Withdrawn by Holder
04 36Blank
01 1218MF10379
02 1223MF10037
03 1227MF10238
04 1228MF10093
05 1302MF10041
06 1306MF10069
07 45Blank
01 1WC-0161
02 1WC-0161A2
03 1WC-0162
04 48Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24630
Submission : 2011-02-11
Status : Active
Type : II
Certificate Number : R0-CEP 2020-194 - Rev 00
Issue Date : 2022-06-23
Type : Chemical
Substance Number : 353
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0025
Start Marketing Date : 2011-08-24
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-28
Pay. Date : 2013-01-03
DMF Number : 3535
Submission : 1979-06-04
Status : Active
Type : II
Certificate Number : R1-CEP 2012-381 - Rev 01
Issue Date : 2021-12-17
Type : Chemical
Substance Number : 353
Status : Valid
Registration Number : 218MF10379
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2006-03-20
Latest Date of Registration : --
NDC Package Code : 82298-104
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Handok Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-71-B-197-03
Manufacturer Name : EUROAPI France
Manufacturer Address : 63480 Vertolyae, France
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8855
Submission : 1990-11-26
Status : Active
Type : II
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 : 27423
Submission : 2013-08-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-06
Pay. Date : 2021-04-09
DMF Number : 34505
Submission : 2020-02-21
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 : 22552-0025
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0025
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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