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Commercial
Scale
Antitubercular
Pyrazinamide
Isoniazid
Rifampicin
Antimalarial
Artesunate
Arteether
Artemether
Dihydroartemisinin
Macrolides
Azithromycin
Erythromycin base
Erythromycin estolate
Erythromycin ethylsuccinate
Erythromycin oxime (intermediate)
Erythromycin phosphate
Erythromycin propionate
Erythromycin stearate
Roxithromycin
Antihypertensive
Lisinopril dihydrate
Losartan potassium
Antiepileptic
Sodium valproate
Valproic acid
Antiosteoporotic
Alendronate sodium
Zoledronic acid
Sedative, Hypnotic
Zopiclone
Antidepressant
Venlafaxine hydrochloride
Antihistaminic
Cetirizine dihydrochloride
Antithrombotic
Clopidogrel bisulphate
Pilot Plant Scale
Carvedilol
Clarithromycin
Pioglitazone hydrochloride
Rosiglitazone maleate
Valsartan
R & D Scale
Lumefantrine
Pamidronate disodium
Perindopril erbumine
Zolpidem tartrate
Development
Benazepril hydrochloride
Candesartan
Desvenlafaxine
Glipizide
Irbesartan
Levocetirizine
Ramipril
Rifabutin
Rifapentine
Risedronic acid
Telmisartan
Product
under patent offered only
for exempted research, clinical
and
development purposes.
Only non-
infrining products
and processes
are offered, subject to
patent status
verification by client. |
Services
• Custom Syntheses
• Contarct Manufacturing
• FTE
Research
• Analytical Support
• Intermediates & APIs
• Building Blocks |
|
|
|
| Analytical
Services at Calyx |
The
Spectrum
• Stability testing
• Analytical method development and Validation
•
Force degradation
• Residual
solvent validation
• Spectral data – NMR (400MHz), GC-MS, LC- MS,
CHONS, FTIR
•
Bio-Analytical services
|
Stability
Testing
•
Long term stability 250C/ 60%RH
•
Intermediate stability 300C/65%RH
• Accelerated
stability conditions 400C/75%RH
• Photo
stability testing
• Conducted as per ICH Q1 A(R2) guidelines |
Method
Validation
• Pre validation study
• Preparation
of validation protocol
•
Conduct
of validation study as per the protocol
•
Validation Report
•
Conducted as per ICH guidelines Q2B
|
Parameters
for method validation:
•
Specificity
• Linearity
•
Accuracy
•
Precision
•
Limit
of detection
• Limit of Quantification
•
Robustness
• Ruggedness
•
Solution stability. |
|
|
|
|
| FTE
Services at Calyx |
| The
Spectrum •
Contract Research
• Custom synthesis
• Process research and development
• Process improvement
• Synthesis of libraries
• Scale up
• GMP Validation batches
• Impurity profiling
• Process and cleaning validation studies
• Analytical method development and validation |
Infrastructure:-
•
Strong R&D … delivering diverse chemistries
from single to multi-step synthesis
• Well equipped Gram to Kilo Level Laboratories
• Well equipped Analytical laboratories including
NMR, GSMS, HPLCs, HPTLC, FTIR, GCs etc.
• More than 200 scientists… postgraduates,
doctorates, post-doctorates and chemical
engineers
• Dedicated Scientists for Informatics …..utilizing
latest chemistry software
• Technology support team
• Regulatory support team
• Teleconferencing and Video conferencing |
Project
Management:-
• Well defined
deliverables
• A dedicated team of scientists/ Project
Managers for each project
• Working 24x7 to honor commitments
with agility
• Involvement of customer during development
• Mutually agreed documentation
• Periodic review
• Knowledge sharing
• Administrative & Legal support for Reporting,
Communications and Confidentiality
• Business Ethics …Respecting CDA
and IPR
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Disclaimer:
"The information in this e-mail and any attachments is
confidential and may be legally privileged. It is intended solely
for the addressee or addressees. If you are not an intended recipient,
please delete the message and any attachments and
notify the sender of misdelivery. Any use or disclosure of the
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unlawful. All liability for viruses is excluded to the
fullest extent permitted by law. Any views expressed
in this message are those of the individual sender, except where
the sender states them, with requisite authority, to be
those of the specific Calyx company." |
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unsubscribe from this Newsletter send blank email to pharmanews@calyxindia.com
|
“Meet
us at ‘InformexUSA 2008’ at Morial Convention Centre,
New Orleans, Louisiana
January 29 – February 1, 2008, at Booth 1707” |
|
