Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.

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01 1Androst Biotech
02 1Shandong Chenghui Shuangda Pharmaceutical
03 1Capital Farma
04 1Swati Spentose
05 1Atomgrid
06 1Bayer AG
07 1Berr Chemical Company Ltd
08 1BrightGene Bio-Medical Technology Co.,Ltd
09 1CHEMO
10 2Chemo Biosynthesis
11 1Gedeon Richter
12 1Green Stone Swiss Co ., Ltd
13 1Guangzhou Tosun Pharmaceutical
14 1Hangzhou Think Chemical Co.Ltd
15 1Henan Lihua Pharmaceutical
16 1Hubei Gedian Humanwell Pharmaceutical
17 3Industriale Chimica
18 1LABORCHEMIE APOLDA GMBH
19 1Lupin Ltd
20 1Maiden Group
21 2NEWCHEM SPA
22 1Naari
23 1Nanjing Bold Chemical
24 1Olon S.p.A
25 1PHARMAZEUTISCHE FABRIK MONTAVIT
26 1Pure Chem India
27 1Qinhuangdao Zizhu Pharmaceutical
28 1Shakti Lifescience
29 1Sterling Spa
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01 1Austria
02 10China
03 2Germany
04 1Hungary
05 8India
06 9Italy
07 2Spain
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01 7Active
02 3Inactive
03 23Blank
01 6Valid
02 27Blank
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01 1227MF10213
02 1228MF10027
03 1228MF10063
04 1306MF10159
05 29Blank
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01 1WC-0419
02 1WC-0561
03 31Blank
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01 1Su236-1-ND
02 1Su236-1-ND(1)
03 1Su236-1-ND(2)
04 1Su242-1-ND
05 1Su2420-4-ND
06 1Su434-58-ND
07 1Su434-58-ND(A)
08 1Su437-1-ND
09 1Su437-1-ND(1)
10 24Blank
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01 124002-0034
02 163190-0270
03 177382-0130
04 30Blank
01 33Blank
Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14014
Submission : 1999-02-26
Status : Active
Type : II
Registrant Name : Bayer Korea Ltd.
Registration Date : 2011-05-16
Registration Number : Su2420-4-ND
Manufacturer Name : Bayer AG, "Bergkamen" (undifferentiated: Bayer AG, "Berlin-Charlottenburg")
Manufacturer Address : Bergkamen Plant: Ernst-Schering-Straße 14, 59192 Bergkamen, Germany (undifferentiated: Berlin-Charlottenburg Plant: Max-Dohrn-Straße 8, 10589 Berlin, Germany)

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37039
Submission : 2022-04-06
Status : Active
Type : II
Certificate Number : CEP 2016-158 - Rev 01
Issue Date : 2025-06-18
Type : Chemical
Substance Number : 2732
Status : Valid
Registration Number : 228MF10063
Registrant's Address : Via Della Carboneria 30 Solomeo 06073 Corciano Perugia-Italy
Initial Date of Registration : 2016-02-24
Latest Date of Registration :
Registrant Name : Darim Biotech Co., Ltd.
Registration Date : 2019-02-11
Registration Number : Su242-1-ND
Manufacturer Name : Sterling SPA@Microchem SRL
Manufacturer Address : Via della Carboneria 30 (loc. Solomeo) - 06073 Corciano - Perugia, Italy@Fiorenzuola D`Arda (PC) - Via Turati 2, Italy

GDUFA
DMF Review : Reviewed
Rev. Date : 2024-11-27
Pay. Date : 2024-10-17
DMF Number : 23428
Submission : 2010-01-05
Status : Active
Type : II
Certificate Number : R1-CEP 2016-333 - Rev 00
Issue Date : 2023-01-20
Type : Chemical
Substance Number : 2732
Status : Valid
Registration Number : 227MF10213
Registrant's Address : Via E. H. Grieg, 13,21047 Saronno (VARESE) ITALY
Initial Date of Registration : 2015-08-31
Latest Date of Registration :
NDC Package Code : 63190-0270
Start Marketing Date : 2010-05-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hanwha Pharmaceutical Co., Ltd.
Registration Date : 2018-10-28
Registration Number : Su236-1-ND(2)
Manufacturer Name : INDUSTRIALE CHIMICA srl
Manufacturer Address : Via EH Grieg, 13, 21047, SARONNO (Varese), Italy

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25251
Submission : 2011-08-14
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28680
Submission : 2014-09-25
Status : Active
Type : II
Certificate Number : CEP 2023-376 - Rev 00
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 2732
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24479
Submission : 2010-12-21
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-023 - Rev 00
Issue Date : 2022-05-03
Type : Chemical
Substance Number : 2732
Status : Valid

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PharmaCompass offers a list of Dienogest API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dienogest manufacturer or Dienogest supplier for your needs.
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A Dienogest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dienogest, including repackagers and relabelers. The FDA regulates Dienogest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dienogest API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Dienogest supplier is an individual or a company that provides Dienogest active pharmaceutical ingredient (API) or Dienogest finished formulations upon request. The Dienogest suppliers may include Dienogest API manufacturers, exporters, distributors and traders.
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