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Copyright©
2000 Pformulate.
All
rights reserved.
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 KALI
LABORATORIES, INC.
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71
Suttons Lane
Piscataway,
NJ 08854
Contact:
Veerappan S. Subramanian, Ph.D
President and CEO
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Phone:
(732) 393-1900
FAX: (732)
393-1700
Email: kalilabs@aol.com
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Description:
Kali Laboratories, Inc. is dedicated to custom development and
commercialization of formulation and delivery systems for solid, liquid and
semi-solid dosage form pharmaceutical products.
Services:
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DEVELOPMENT:
Comprehensive product development from concept to market launch; Building
R&D teams and facilities; Selection
of products for development; Worldwide sourcing of active drug substances
and excipients; Interfacing with CROs for bioequivalence and clinical
studies.
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ANALYTICAL:
Test methods development and
validation for active drug substances, intermediates and finished
products; Stability studies; Pre-formulation:
Characterization of drug substances and excipients.
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FORMULATION:
Formulation and product feasibility; Formulation optimization; Dosage form
determination/formula development; Engineering product
formulation/processes to custom fit client facilities/equipment. |
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DOCUMENTATION:
Batch records and development
reports; Excipients, raw materials, intermediates and finished products
specifications; ANDA, IND, NDA documentation support |
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MANUFACTURING:
Regulatory batch manufacturing;
Scale-up manufacturing and process validation support; Technology
transfer.
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REGULATORY:
Regulatory and compliance
strategies; FDA pre-approval and pre-market validation support.
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Pformulate/10/18/2000
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