Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Veranova
03 1Minakem (formerly Delmar Chemicals)
04 1LGM Pharma
05 1Aspen API
06 1Fine Chemicals Corporation PTY Ltd
07 1Rusan Pharma
08 1Tofigh Daru
09 1American Pacific Corporation
10 1Apothecon Pharmaceuticals
11 1Arevipharma
12 1Chr. Olesen Synthesis A.S
13 1Cilag AG
14 1Hameln rds
15 1Kern Pharma S.L.
16 1Kimyagaran
17 1OmnisMed Pharmaceuticals
18 2Pioneer Agro Extracts
19 1Yichang Humanwell Pharmaceutical
01 1Canada
02 1China
03 1Denmark
04 1France
05 1Germany
06 4India
07 2Iran
08 1Netherlands
09 1Slovakia
10 1South Africa
11 1Spain
12 1Switzerland
13 3U.S.A
14 1United Kingdom
01 6Active
02 14Blank
01 8Valid
02 12Blank
01 1226MF10170
02 19Blank
01 1WC-0174
02 1WC-0174a1
03 18Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : R0-CEP 2020-323 - Rev 00
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 2644
Status : Valid
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2014-10-28
Registration Number : Su2480-16-ND
Manufacturer Name : Minakem High Potent SA
Manufacturer Address : Rue Fonds Jean Paques 8, Mont-Saint-Guibert, 1435 Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25811
Submission : 2011-12-22
Status : Active
Type : II
Certificate Number : CEP 2018-137 - Rev 01
Issue Date : 2024-08-06
Type : Chemical
Substance Number : 2644
Status : Valid
NDC Package Code : 49812-0190
Start Marketing Date : 2012-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom_x000D_
Available Reg Filing : ROW |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-30
Pay. Date : 2014-12-04
DMF Number : 28106
Submission : 2014-03-13
Status : Active
Type : II
Available Reg Filing : ASMF |
Certificate Number : CEP 2018-240 - Rev 03
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 2644
Status : Valid
NDC Package Code : 48954-724
Start Marketing Date : 2007-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-02-26
Registration Number : No. 181-3-ND(1)
Manufacturer Name : Fine Chemicals Corporation
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-14
Pay. Date : 2021-02-17
DMF Number : 34303
Submission : 2020-11-18
Status : Active
Type : II
NDC Package Code : 50683-0550
Start Marketing Date : 2020-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-28
Pay. Date : 2013-09-26
DMF Number : 27513
Submission : 2013-09-06
Status : Active
Type : II
Certificate Number : R0-CEP 2018-296 - Rev 01
Issue Date : 2022-03-22
Type : Chemical
Substance Number : 2644
Status : Valid
NDC Package Code : 12502-5343
Start Marketing Date : 2013-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-21
Pay. Date : 2018-09-28
DMF Number : 33151
Submission : 2018-09-21
Status : Active
Type : II
Certificate Number : CEP 2018-193 - Rev 01
Issue Date : 2023-10-30
Type : Chemical
Substance Number : 2644
Status : Valid
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2020-03-25
Registration Number : Su207-28-ND(3)
Manufacturer Name : Yichang Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No. 19, Dalian Road, Yichang Developing zone, Hubei Province, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-04-07
Pay. Date : 2016-09-26
DMF Number : 30156
Submission : 2016-09-27
Status : Active
Type : II
Certificate Number : CEP 2018-070 - Rev 01
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 2644
Status : Valid
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2024-12-06
Registration Number : No. 75-4-ND(A)
Manufacturer Name : Arevipharma GmbH
Manufacturer Address : Meissner Str.35, D-01445 Radebeul, Germany
Date of Issue : 2019-09-12
Valid Till : 2022-09-11
Written Confirmation Number : WC-0174a1
Address of the Firm :
Date of Issue : 2019-09-12
Valid Till : 2021-09-11
Written Confirmation Number : WC-0174
Address of the Firm :
Certificate Number : R1-CEP 2017-065 - Rev 00
Issue Date : 2023-01-20
Type : Chemical
Substance Number : 2644
Status : Valid
Registration Number : 226MF10170
Registrant's Address : Pol. Ind. Colo(´)n II Venus, 72 08228 Terrassa (Barcelona)-Spain
Initial Date of Registration : 2014-09-01
Latest Date of Registration : --
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2016-08-29
Registration Number : Su3058-1-ND
Manufacturer Name : Kern Pharma SL
Manufacturer Address : Poligon Industrial Colon Ⅱ, c /Venus, 72, 08228, Terrasa (Barcelona), Spain
Certificate Number : CEP 2018-125 - Rev 04
Issue Date : 2024-03-20
Type : Chemical
Substance Number : 2644
Status : Valid
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2023-04-17
Registration Number : Number 9-1-ND
Manufacturer Name : Hameln rds sro
Manufacturer Address : Horná 36, 900 01 Modra, Slovak Republic
A Remifentanil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remifentanil, including repackagers and relabelers. The FDA regulates Remifentanil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remifentanil 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 Remifentanil supplier is an individual or a company that provides Remifentanil active pharmaceutical ingredient (API) or Remifentanil finished formulations upon request. The Remifentanil suppliers may include Remifentanil API manufacturers, exporters, distributors and traders.
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