With Fermion, start the journey of your innovative API.
01 2Fermion Oy
02 1Pfanstiehl
03 1Rochem International Inc
04 1LGM Pharma
05 1Cohance Lifesciences
06 2Fareva
07 1Jai Radhe Sales
08 1CF Pharma
09 1HRV Global Life Sciences
10 1Sichuan Elixir Pharmaceuticals
11 1Farmhispania
12 1Porton Pharma Solutions
13 1Alembic Pharmaceuticals Limited
14 1Aspen Biopharma Labs
15 1BEDFORD LABS
16 1Beijing Mesochem Technology
17 1Benzo Chem Industries Pvt. Ltd.
18 1Biesterfeld Spezialchemie GmbH
19 1Biovectra Inc
20 1Bulat Pharmaceutical
21 1Fujian South Pharmaceutical
22 1Hangzhou Think Chemical Co.Ltd
23 2Huzhou Zhanwang Pharmaceutical Co.,Ltd.
24 1LIANYUNGANG GUIKE PHARMACEUTICAL
25 1Mac-Chem Products (India) Pvt.Ltd
26 1Mitsubishi Corporation
27 1Pfizer Inc
28 1SAMEX OVERSEAS
29 1SEACROSS PHARMACEUTICALS
30 1SIGMA TAU
31 1Sakar Healthcare
32 1Sichuan Huiyu Pharmaceutical
33 1Sichuan Xieli Pharmaceutical
34 1Stason Pharmaceuticals, Inc.
35 1Surajlok Chemicals
36 1Tecoland Corporation
37 1Zhejiang Hisun Pharmaceutical
38 5Blank
01 1Canada
02 11China
03 2Finland
04 1Germany
05 1Hungary
06 11India
07 1Japan
08 2Luxembourg
09 1Spain
10 8U.S.A
11 1United Kingdom
12 5Blank
01 11Active
02 10Inactive
03 24Blank
01 5Valid
02 2Withdrawn by Holder
03 38Blank
01 1219MF10359
02 1219MF10360
03 1220MF10179
04 1229MF10125
05 41Blank
01 1WC-0082
02 1WC-0275
03 1WC-0435
04 42Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-08
Pay. Date : 2013-05-23
DMF Number : 4246
Submission : 1981-08-06
Status : Active
Type : II
Certificate Number : R1-CEP 2001-145 - Rev 04
Issue Date : 2018-10-26
Type : Chemical
Substance Number : 560
Status : Valid
Registration Number : 219MF10359
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2007-12-13
Latest Date of Registration : --
NDC Package Code : 12780-0491
Start Marketing Date : 1981-11-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, BR |
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39988
Submission : 2024-06-05
Status : Active
Type : II
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 11704
Submission : 1995-10-05
Status : Active
Type : II
Certificate Number : R0-CEP 2022-373 - Rev 00
Issue Date : 2022-12-13
Type : Chemical
Substance Number : 560
Status : Valid
Registration Number : 219MF10360
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2007-12-13
Latest Date of Registration : --
NDC Package Code : 46014-1023
Start Marketing Date : 2013-05-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : ASMF, CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25957
Submission : 2012-04-10
Status : Active
Type : II
Certificate Number : R1-CEP 2008-238 - Rev 02
Issue Date : 2020-02-07
Type : Chemical
Substance Number : 560
Status : Valid
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39758
Submission : 2024-03-24
Status : Active
Type : II
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