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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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JDMF
NDC
KDMF
VMF 
IN, ROW
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
CEP/COS
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
EU-WC
NDC
Axplora- The partner of choice for complex APIs.
NDC
EU
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CEP/COS
NDC
KDMF
VMF
IN, ROW
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2736
Submission : 1976-07-19
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-18
DMF Number : 1748
Submission : 1971-06-21
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 4524
Submission : 1982-05-10
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12127
Submission : 1996-09-11
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4532
Submission : 1982-05-10
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-26
Pay. Date : 2023-10-03
DMF Number : 38162
Submission : 2023-03-29
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-09
Pay. Date : 2018-03-15
DMF Number : 31532
Submission : 2017-03-10
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : CEP 1996-019 - Rev 09
Status : Valid
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 388
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 1998-089 - Rev 07
Status : Valid
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 548
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Certificate Number : R1-CEP 2000-261 - Rev 05
Status : Valid
Issue Date : 2022-09-02
Type : Chemical
Substance Number : 388
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
Axplora- The partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%
USFDA APPLICATION NUMBER - 13422
DOSAGE - SUSPENSION/DROPS;OTIC - 0.3%;0.1%
USFDA APPLICATION NUMBER - 21537
DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG ...DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50065
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%
USFDA APPLICATION NUMBER - 50592
DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;0.3%
USFDA APPLICATION NUMBER - 50616
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.05%;...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%
USFDA APPLICATION NUMBER - 50818
DOSAGE - TABLET;ORAL - 1.5MG
USFDA APPLICATION NUMBER - 84610
DOSAGE - TABLET;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 84611
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 84612
DOSAGE - TABLET;ORAL - 0.75MG
USFDA APPLICATION NUMBER - 84613
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 87916
DOSAGE - SOLUTION;ORAL - 0.5MG/5ML
USFDA APPLICATION NUMBER - 88248
DOSAGE - ELIXIR;ORAL - 0.5MG/5ML
USFDA APPLICATION NUMBER - 88254
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 88306
DOSAGE - TABLET;ORAL - 6MG
USFDA APPLICATION NUMBER - 88316
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