Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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01 1Minakem
02 1Gonane Pharma
03 1Axplora
04 1Minakem (formerly Delmar Chemicals)
05 1LGM Pharma
06 1Jinan Tantu Chemicals
07 1Capital Farma
08 2TAPI Technology & API Services
09 1Sumar Biotech
10 1Ajinomoto Company
11 1AstraZeneca
12 1BDR Lifesciences
13 1CHEMO
14 1Chongqing Huapont Pharmaceutical
15 1Fujian South Pharmaceutical
16 1GLAND PHARMA LIMITED
17 1Guangzhou Topwork Chemical
18 1Guangzhou Tosun Pharmaceutical
19 1Hangzhou Jiuyuan Gene Engineering
20 1Hangzhou Longshine Bio-Tech
21 1Hansoh Pharma
22 1Hanways Chempharm
23 3Industriale Chimica
24 1Jiangsu Sinopep Allsino Biopharmaceutical
25 1Lianyungang Runzhong Pharmaceutical Co Ltd
26 1Maharshi Pharma Chem
27 1Sakar Healthcare
28 1ScinoPharm Taiwan Ltd
29 1Shouyuan Chemical
30 1Sicor
31 1Sicor Societa Italiana Corticosteroidi Srl
32 1Sterling Chemical Malta
33 2Sterling Spa
34 1Steroid SpA
35 1Sun Pharmaceutical Industries Limited
36 1Tecoland Corporation
37 1Teva Pharmaceutical Industries
38 1Xian Libang Pharmaceutical Co.,Ltd
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01 1Canada
02 13China
03 1France
04 1Germany
05 7India
06 3Israel
07 8Italy
08 1Japan
09 1Malta
10 2Spain
11 1Taiwan
12 2U.S.A
13 1United Kingdom
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01 12Active
02 1Inactive
03 29Blank
01 9Valid
02 33Blank
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01 1303MF10021
02 1303MF10127
03 40Blank
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01 1WC-0159
02 1WC-0340
03 1WC-0570
04 39Blank
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01 1No. 249-7-ND(A)
02 1No. 661-4-ND
03 1No. 936-1-ND
04 1Su248-17-ND
05 1Su249-7-ND
06 1Su249-7-ND(B)
07 1Su3042-8-ND
08 1Su532-9-ND
09 34Blank
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01 146439-8769
02 150923-0416
03 153183-9305
04 159057-003
05 161662-0011
06 163190-0300
07 164918-1402
08 165129-2149
09 166529-0014
10 169910-0001
11 176177-053
12 31Blank
01 42Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : CEP 2024-002 - Rev 00
Issue Date : 2024-10-15
Type : Chemical
Substance Number : 2443
Status : Valid
NDC Package Code : 69910-0001
Start Marketing Date : 2015-06-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2014-10-24
Registration Number : Su3042-8-ND
Manufacturer Name : Minakem High Potent SA
Manufacturer Address : Rue Fonds Jean Paques, 8, Mont-Saint-Guibert, 1435, Belgium
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-29
Pay. Date : 2020-07-17
DMF Number : 32949
Submission : 2018-07-27
Status : Active
Type : II
Certificate Number : R1-CEP 2016-169 - Rev 00
Issue Date : 2023-02-22
Type : Chemical
Substance Number : 2443
Status : Valid
NDC Package Code : 46439-8769
Start Marketing Date : 2020-07-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22174
Submission : 2008-11-12
Status : Inactive
Type : II
Certificate Number : R1-CEP 2013-255 - Rev 02
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 2443
Status : Valid
Available Reg Filing : CA, ASMF |
Date of Issue : 2023-09-29
Valid Till : 2026-09-28
Written Confirmation Number : WC-0570
Address of the Firm :
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-27
Pay. Date : 2013-02-20
DMF Number : 26835
Submission : 2013-03-15
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
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PharmaCompass offers a list of Fulvestrant 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 Fulvestrant manufacturer or Fulvestrant supplier for your needs.
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A Fulvestrant supplier is an individual or a company that provides Fulvestrant active pharmaceutical ingredient (API) or Fulvestrant finished formulations upon request. The Fulvestrant suppliers may include Fulvestrant API manufacturers, exporters, distributors and traders.
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