Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 1EUROAPI
03 1Sanofi
04 1LGM Pharma
05 1Aspen API
06 1HRV Global Life Sciences
07 1Hubei Gedian Humanwell Pharmaceutical
08 2Supriya Lifescience
09 13M Drug Delivery Systems
10 1ASG Biochem
11 1Arudavis Labs
12 1Atomgrid
13 1Balaji Corporation
14 1Bayer AG
15 1CHEMO
16 1Cygnus Inc
17 3Gedeon Richter
18 1Hangzhou Longshine Bio-Tech
19 1Industriale Chimica
20 1Jenapharm GmbH & Co KG DE 07745 Jena
21 1Laboratorios Leon Farma
22 1Lupin Ltd
23 1Merck & Co
24 1Naari
25 1Nanjing Bold Chemical
26 1Pfizer Inc
27 1Qinhuangdao Zizhu Pharmaceutical
28 1Swati Spentose
29 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
30 2Zhejiang Xianju Pharmaceutical Co. Ltd
01 7China
02 2France
03 2Germany
04 3Hungary
05 12India
06 1Italy
07 1Netherlands
08 2Spain
09 5U.S.A
01 6Active
02 7Inactive
03 22Blank
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
04 25Blank
01 1218MF10829
02 1218MF10848
03 1228MF10156
04 1303MF10036
05 31Blank
01 1WC-0161A2
02 1WC-0162
03 33Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-20
Pay. Date : 2020-03-24
DMF Number : 26020
Submission : 2012-05-02
Status : Active
Type : II
Certificate Number : R0-CEP 2020-029 - Rev 00
Issue Date : 2021-10-06
Type : Chemical
Substance Number : 140
Status : Valid
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0034
Start Marketing Date : 2012-06-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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 : 2425
Submission : 1975-03-27
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-04
Pay. Date : 2012-11-14
DMF Number : 3803
Submission : 1980-05-20
Status : Active
Type : II
Certificate Number : R2-CEP 1995-022 - Rev 05
Issue Date : 2014-01-30
Type : Chemical
Substance Number : 140
Status : Valid
Registration Number : 218MF10848
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-10-20
Latest Date of Registration : --
NDC Package Code : 60870-0463
Start Marketing Date : 1980-04-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0034
Start Marketing Date : 2012-06-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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