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 1Anuh Pharma LTD
09 1Arudavis Labs
10 1Aurisco Pharmaceutical
11 2Bayer AG
12 1Biotechnica DWC
13 1DMFs Not Supported
14 3Fujifilm Diosynth Biotechnologies
15 3Henan Lihua Pharmaceutical
16 1Hengdian Group
17 1Hunan Yuxin Pharmaceutical Co., Ltd.
18 1JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTD
19 1Laboratorio Syntex S.A
20 1Mahima Life Sciences
21 1Medimpex
22 1Merck & Co
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
38 1Blank
01 1Algeria
02 1Argentina
03 17China
04 3France
05 4Germany
06 8India
07 1Israel
08 3Italy
09 2Malaysia
10 1Netherlands
11 5U.S.A
12 4United Kingdom
13 2Blank
01 10Active
02 12Inactive
03 30Blank
01 2Expired
02 12Valid
03 1Withdrawn by Holder
04 37Blank
01 1218MF10379
02 1223MF10037
03 1227MF10238
04 1228MF10093
05 1302MF10041
06 1306MF10069
07 46Blank
01 1WC-0161
02 1WC-0161A2
03 1WC-0162
04 49Blank
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
Certificate Number : R2-CEP 1992-015 - Rev 05
Issue Date : 2021-12-17
Type : Chemical and TSE
Substance Number : 353
Status : Valid
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 |
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