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 1Sigmak Lifesciences
12 1Farmhispania
13 1Porton Pharma Solutions
14 1Alembic Pharmaceuticals Limited
15 1Aspen Biopharma Labs
16 1BEDFORD LABS
17 1Beijing Mesochem Technology
18 1Benzo Chem Industries Pvt. Ltd.
19 1Biesterfeld Spezialchemie GmbH
20 1Biovectra Inc
21 1Bulat Pharmaceutical
22 1Fujian South Pharmaceutical
23 1Hangzhou Think Chemical Co.Ltd
24 2Huzhou Zhanwang Pharmaceutical Co.,Ltd.
25 1LIANYUNGANG GUIKE PHARMACEUTICAL
26 1Mac-Chem Products (India) Pvt.Ltd
27 1Mitsubishi Corporation
28 1Pfizer Inc
29 1SAMEX OVERSEAS
30 1SEACROSS PHARMACEUTICALS
31 1SIGMA TAU
32 1Sakar Healthcare
33 1Sichuan Huiyu Pharmaceutical
34 1Sichuan Xieli Pharmaceutical
35 1Stason Pharmaceuticals, Inc.
36 1Surajlok Chemicals
37 1Tecoland Corporation
38 1Zhejiang Hisun Pharmaceutical
39 5Blank
01 1Canada
02 11China
03 2Finland
04 1Germany
05 1Hungary
06 12India
07 1Japan
08 2Luxembourg
09 1Spain
10 8U.S.A
11 1United Kingdom
12 5Blank
01 11Active
02 10Inactive
03 25Blank
01 5Valid
02 2Withdrawn by Holder
03 39Blank
01 1219MF10359
02 1219MF10360
03 1220MF10179
04 1229MF10125
05 42Blank
01 1WC-0082
02 1WC-0275
03 1WC-0435
04 43Blank
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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