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13 Feb 2025
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https://www.axplora.com/axplora-invests-e8-million-in-le-mans-to-further-expand-its-capacity-for-antibody-drug-conjugate-manufacturing/
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-07
Pay. Date : 2013-04-03
DMF Number : 5836
Submission : 1985-03-29
Status : Active
Type : II
Certificate Number : R2-CEP 1995-028 - Rev 04
Issue Date : 2020-12-15
Type : Chemical
Substance Number : 967
Status : Valid
Registration Number : 219MF10377
Registrant's Address : ROSENHEIMER STR. 43, D-83064 RAUBLING, GERMARY
Initial Date of Registration : 2007-12-19
Latest Date of Registration :
NDC Package Code : 12598-7027
Start Marketing Date : 1995-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
Available Reg. Filing : EU, CA, BR, CN |
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-09
DMF Number : 12749
Submission : 1997-11-18
Status : Active
Type : II
Certificate Number : R1-CEP 2002-078 - Rev 03
Issue Date : 2021-03-22
Type : Chemical
Substance Number : 811
Status : Valid
Registration Number : 304MF10098
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2022-07-06
Latest Date of Registration :
NDC Package Code : 46439-8711
Start Marketing Date : 1989-05-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-23
Pay. Date : 2015-02-17
DMF Number : 8336
Submission : 1989-12-09
Status : Active
Type : II
Certificate Number : R1-CEP 2011-135 - Rev 03
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 2127
Status : Valid
Registration Number : 222MF10130
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2010-04-12
Latest Date of Registration :
NDC Package Code : 46439-8784
Start Marketing Date : 2025-02-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Galderma Korea Co., Ltd.
Registration Date : 2012-11-22
Registration Number : 20121123-93-E-100-06
Manufacturer Name : Farmabios SpA
Manufacturer Address : via Pavia 1 27027 GROPELLO CAIROLI (PV) (microchem SRL, Via Turati 2 IT-29017 Fiorenzuola D'Arda (PC), Italy)
Available Reg. Filing : SAU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12695
Submission : 1997-10-15
Status : Active
Type : II
Certificate Number : R1-CEP 2002-191 - Rev 03
Issue Date : 2023-07-03
Type : Chemical
Substance Number : 673
Status : Valid
Registration Number : 222MF10098
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2010-03-17
Latest Date of Registration :
NDC Package Code : 46439-8749
Start Marketing Date : 2015-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-58-B-142-01
Manufacturer Name : Farmabios SpA
Manufacturer Address : Farmabios SpA via Pavia 1 27027 GROPELLO CAIROLI-Pavia ITALY
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 8070
Submission : 1989-05-09
Status : Active
Type : II
Certificate Number : CEP 2003-203 - Rev 03
Issue Date : 2023-11-08
Type : Chemical
Substance Number : 1699
Status : Valid
Registration Number : 219MF10036
Registrant's Address : ROSENHEIMER STR. 43 D-83064 RAUBLING, Germany
Initial Date of Registration : 2007-02-13
Latest Date of Registration :
NDC Package Code : 12598-5163
Start Marketing Date : 2016-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Takeda Pharmaceutical Company Korea Ltd.
Registration Date : 2021-10-05
Registration Number : 20210521-209-J-766(1)
Manufacturer Name : PharmaZell (India) Private Ltd
Manufacturer Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli – 531019 Andhra Pradesh, India
Available Reg. Filing : EU, CA, TW, BR, TH |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2013-05-14
DMF Number : 14693
Submission : 2000-02-01
Status : Active
Type : II
Certificate Number : R1-CEP 2000-075 - Rev 07
Issue Date : 2021-02-25
Type : Chemical
Substance Number : 533
Status : Valid
Registration Number : 305MF10085
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2023-07-19
Latest Date of Registration :
NDC Package Code : 46439-8782
Start Marketing Date : 2025-02-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2015-01-30
Registration Number : 20150130-65-B-382-10
Manufacturer Name : Farmabios SpA
Manufacturer Address : Via Pavia 1-27027 Gropello Cairoli(PV), Italy_x000D_
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-20
Pay. Date : 2013-01-10
DMF Number : 21591
Submission : 2008-05-01
Status : Active
Type : II
Certificate Number : R0-CEP 2021-315 - Rev 00
Issue Date : 2021-12-21
Type : Chemical
Substance Number : 533
Status : Valid
Registration Number : 223MF10049
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2011-04-12
Latest Date of Registration :
NDC Package Code : 46439-8783
Start Marketing Date : 2025-02-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-25
Pay. Date : 2019-04-22
DMF Number : 12813
Submission : 1998-01-05
Status : Active
Type : II
Certificate Number : R1-CEP 2001-315 - Rev 02
Issue Date : 2017-06-28
Type : Chemical
Substance Number : 654
Status : Valid
NDC Package Code : 46439-8785
Start Marketing Date : 2025-03-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-285-01
Manufacturer Name : Farmabios SpA
Manufacturer Address : Gropello Cairoli (PV) - Via Pavia, 1, Italy.
Available Reg. Filing : CN, SAU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-25
Pay. Date : 2021-03-22
DMF Number : 12662
Submission : 1997-09-20
Status : Active
Type : II
Certificate Number : CEP 2002-181 - Rev 09
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 1593
Status : Valid
NDC Package Code : 46439-8722
Start Marketing Date : 1998-07-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-04-09
Registration Number : 20210409-211-J-738
Manufacturer Name : Farmabios SpA@Micro-Macinazione SA@IMS srl@Micro-Macinazione SA
Manufacturer Address : Via Pavia 1-27027 Gropello Cairoli (PV), Italy@Zona Artigianale 11, 6995 Madonna del Piano, Switzerland@Via Venezia Giulia 23, 20157 Milano@Via Cantonale 4, 6998 Monteggio, Switzerland
Product Not Available For Sales
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12294
Submission : 1996-12-27
Status : Active
Type : II
Certificate Number : R1-CEP 2008-327 - Rev 00
Issue Date : 2014-09-02
Type : Chemical
Substance Number : 1794
Status : Valid
NDC Package Code : 62422-0002
Start Marketing Date : 1996-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Services
API Manufacturing
API & Drug Product Development
Excipients
Inspections and registrations
ABOUT THIS PAGE
Axplora is a supplier offers 143 products (APIs, Excipients or Intermediates).
Find a price of Acetylcysteine bulk with DMF, CEP, JDMF offered by Axplora
Find a price of Betamethasone Valerate bulk with DMF, CEP, JDMF offered by Axplora
Find a price of Clobetasol Propionate bulk with DMF, CEP, JDMF offered by Axplora
Find a price of Medroxyprogesterone Acetate bulk with DMF, CEP, JDMF offered by Axplora
Find a price of Mesalazine bulk with DMF, CEP, JDMF offered by Axplora
Find a price of Triamcinolone Acetonide bulk with DMF, CEP, JDMF offered by Axplora
Find a price of Beclomethasone Dipropionate bulk with DMF, CEP offered by Axplora
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Find a price of Budesonide bulk with DMF, CEP offered by Axplora
Find a price of Carbocisteine bulk with CEP, JDMF offered by Axplora
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