Production Capacity

With state-of-the-art resources combined with highly skilled contract manufacturing team, we are cGMP compliant, responsive, attentive, flexible and trustworthy.

Cenra API Solutions is an outstanding choice of partner that offers clients the highest value. Our goal is not only to establish a win-win partnership with our clients, but also to enhance global human health and well-being through pharmaceutical research and development.

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Specification

DMF

Inspection/GMP certification

Status

Market

Anidulafungin
Anidulafungin
Category
Antifungal
CAS
166663-25-8
Specification
In-House
US DMF
N/A
DMF
-
GMP certification
N/A
Inspection
N/A
Status
Investigation
Major Market
US, EU, Japan
Caspofungin Acetate
Caspofungin Acetate
Category
Antifungal
CAS
179463-17-3
Specification
In-House
US DMF
27585
DMF
EDMF
GMP certification
TFDA, COFEPRIS
Inspection
TFDA, COFEPRIS
Status
Commercial
Major Market
US, EU
Rezafungin acetate
Rezafungin acetate
Category
Antifungal
CAS
1631754-41-0
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Investigation
Major Market
US, EU, Japan
Everolimus
Everolimus
Category
Immunosuppressant
CAS
159351-69-6
Specification
EP / USP
US DMF
26819/27216
DMF
CEP / EDMF
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
US, EU
Mycophenolate Mofetil HCl
Mycophenolate Mofetil HCl
Category
Immunosuppressant
CAS
116680-01-4
Specification
In-House
US DMF
24372
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
US
Mycophenolate Mofetil
Mycophenolate Mofetil
Category
Immunosuppressant
CAS
128794-94-5
Specification
EP / USP
US DMF
18494/33333
DMF
EDMF
GMP certification
FDA, TFDA
Inspection
FDA, TFDA
Status
Commercial
Major Market
US, EU
Mycophenolate Sodium
Mycophenolate Sodium
Category
Immunosuppressant
CAS
37415-62-6
Specification
EP / USP
US DMF
35848
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
US
Rapamycin (Sirolimus)
Rapamycin (Sirolimus)
Category
Immunosuppressant
CAS
53123-88-9
Specification
In-House
US DMF
17399/31189
DMF
EDMF
GMP certification
TFDA, PMDA
Inspection
TFDA, PMDA
Status
Commercial
Major Market
US, EU, Japan
Tacrolimus
Tacrolimus
Category
Immunosuppressant
CAS
109581-93-3
Specification
EP / JP / USP
US DMF
18985/38310
DMF
CEP / EDMF
GMP certification
EU (Germany), FDA, TFDA, PMDA
Inspection
EU (Germany), FDA, TFDA, PMDA
Status
Commercial
Major Market
US, EU, Japan
Midostaurin
Midostaurin
Category
Oncology
CAS
120685-11-2
Specification
In-House
US DMF
036640
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Commercial
Major Market
US, EU, Japan
Palbociclib
Palbociclib
Category
Oncology
CAS
571190-30-2
Specification
In-House
US DMF
37586
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Completed process development
Major Market
US, EU, Japan
Ribociclib succinate
Ribociclib succinate
Category
Oncology
CAS
1374639-75-4
Specification
In-House
US DMF
036174
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Completed process development
Major Market
US, EU, Japan
Ethyl Icosapentate
Ethyl Icosapentate
Category
Cardiovascular
CAS
86227-47-6
Specification
In-House
US DMF
26271
DMF
N/A
GMP certification
FDA, TFDA
Inspection
FDA, TFDA
Status
Commercial
Major Market
US
Trandolapril
Trandolapril
Category
Cardiovascular
CAS
87679-37-6
Specification
EP / USP
US DMF
N/A
DMF
EDMF
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
EU, Japan
Abaloparatide
Abaloparatide
Category
Peptide Drug
CAS
247062-33-5
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU, Japan
Difelikefalin Acetate
Difelikefalin Acetate
Category
Peptide Drug
CAS
1024829-44-4
Specification
In-House
US DMF
38511
DMF
N/A
GMP certification
TFDA
Inspection
-
Status
Completed process development
Major Market
US
Etelcalcetide HCl
Etelcalcetide HCl
Category
Peptide Drug
CAS
1334237-71-6
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU, Japan
Lanreotide Acetate
Lanreotide Acetate
Category
Peptide Drug
CAS
127984-74-1
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU, Japan
Plecanatide
Plecanatide
Category
Peptide Drug
CAS
467426-54-6
Specification
In-House
US DMF
41493
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU, Japan
Semaglutide
Semaglutide
Category
Peptide Drug
CAS
910463-68-2
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU
Setmelanotide Acetate
Setmelanotide Acetate
Category
Peptide Drug
CAS
1504602-49-6
Specification
In-House
US DMF
41490
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Completed process development
Major Market
US, EU, Japan
Favipiravir
Favipiravir
Category
Anti-virus
CAS
259793-96-9
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Commercial
Major Market
US, EU, Japan
Baricitinib
Baricitinib
Category
Immunomodulating Agents
CAS
1187594-09-7
Specification
In-House
US DMF
36030
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Completed process development
Major Market
US, EU, Japan
Ozanimod Hydrochloride
Ozanimod Hydrochloride
Category
Immunomodulating Agents
CAS
1618636-37-5
Specification
In-House
US DMF
37597
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
US, EU, Japan
Tofacitinib Citrate
Tofacitinib Citrate
Category
Immunomodulating Agents
CAS
540737-29-9
Specification
In-House
US DMF
37532
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
US, EU, Japan
Brivaracetam
Brivaracetam
Category
Others
CAS
357336-20-0
Specification
EP
US DMF
41491
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Completed process development
Major Market
US, EU, Japan
Dalbavancin Hydrochloride
Dalbavancin Hydrochloride
Category
Others
CAS
2227366-51-8
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Investigation
Major Market
US
Edoxaban Tosylate Monohydrate
Edoxaban Tosylate Monohydrate
Category
Others
CAS
1229194-11-9
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU, Japan
Eltrombopag Olamine
Eltrombopag Olamine
Category
Others
CAS
496775-62-3
Specification
In-House
US DMF
40868
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Completed process development
Major Market
US, EU, Japan
Eslicarbazepine acetate
Eslicarbazepine acetate
Category
Others
CAS
236395-14-5
Specification
In-House
US DMF
039312
DMF
N/A
GMP certification
TFDA
Inspection
TFDA
Status
Commercial
Major Market
US, EU, Japan
Selumetinib Sulfate
Selumetinib Sulfate
Category
Others
CAS
943332-08-9
Specification
In-House
US DMF
41492
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US
Sugammadex Sodium
Sugammadex Sodium
Category
Others
CAS
343306-79-6
Specification
In-House
US DMF
N/A
DMF
EDMF
GMP certification
TFDA
Inspection
TFDA
Status
Completed process development
Major Market
EU, Japan, Turkey
Tenapanor HCl
Tenapanor HCl
Category
Others
CAS
1234365-97-9
Specification
In-House
US DMF
N/A
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Investigation
Major Market
US, EU, Japan
Trilaciclib Dihydrochloride
Trilaciclib Dihydrochloride
Category
Others
CAS
1977495-97-8
Specification
In-House
US DMF
41494
DMF
N/A
GMP certification
N/A
Inspection
N/A
Status
Development
Major Market
US, EU, Japan