Active Pharmaceutical Ingredient(API)
The API plant of the oncology set-up at Sakar caters to the manufacturing from gram to kilogram scale under GMP environment that have four sections. The Glass-line reactors from De-Dietrich, the leading provider for process equipment worldwide, have been installed to make the API Processing plant efficient and regulatory compliant. The cytotoxic materials (API and intermediates) are meant to get handled in totally close loop with use of negative pressure isolator in this set up. Total safety precaution has been installed during the manufacturing by using PPEs. The deactivation of effluent is managed through a separate unit. Thus dedicated manpower and containment safety systems with the lowest occupational exposure limits, the quality of products as well as the health and safety of professionals are well taken care off.
Products |
Specification |
Document |
Anastrazole |
USP/BP/IP |
T.P |
Abiraterone |
USP/IP |
T.P |
Bendamustine |
IP |
T.P |
Capacitabine |
USP/BP/IP |
T.P |
Erlotinib |
IP |
T.P |
Gefitinib |
IP/BP |
T.P |
Imatinib |
IP/BP |
T.P |
Bicalutamide Tab. |
USP/BP/IP |
T.P |
Products |
Specification |
Document |
Busulfan Inj. |
USP/BP |
T.P |
Gemcitabine HCl Inj. |
USP/BP/IP |
T.P |
Irinotecan HCl |
USP/BP/IP |
T.P |
Methotrexate Inj. / Tab. |
USP/BP/IP |
T.P |
Topotecan Inj. |
IP |
T.P |
Cyterabine Inj. |
USP/BP/IP |
T.P |
Thiotepa Inj. |
USP/BP/IP |
T.P |
Products |
Specification |
Document |
Aprepritant |
USP/BP/IP |
R&D |
Clofarabine |
IHS |
R&D |
Carboplatin |
USP/BP/IP |
R&D |
Cisplatin |
USP/BP/IP |
R&D |
Carmustine |
USP/BP/IP |
R&D |
Docetaxel |
USP/BP/IP |
R&D |
Etoposide |
USP/BP/IP |
R&D |
Products |
Specification |
Document |
Fosaprepitant |
IHS |
R&D |
Lenalidomide |
IHS |
R&D |
Letrozole |
USP/BP/IP |
R&D |
Oxaliplatin |
USP/BP/IP |
R&D |
Ondansetron |
USP/BP/IP |
R&D |
Pemetrexed Dipotassium |
USP/BP/IP |
R&D |
Temozolamide |
USP/BP/IP |
R&D |
Products |
Specification |
Document |
Axitinib |
IHS |
R&D |
Azacitadine |
IP |
R&D |
Afatinib |
IHS |
R&D |
Bortezomib |
IP |
R&D |
Cyclophosphamide |
USP/BP/IP |
R&D |
Carfilozomib |
IHS |
R&D |
Dasatinib |
IHS |
R&D |
Decitabine |
IHS |
R&D |
Doxorubicin HCl |
USP/BP/IP |
R&D |
Daunorubicin |
USP/BP/IP |
R&D |
Dutasteride |
USP/BP/IP |
R&D |
Exemestane |
USP/BP/IP |
R&D |
Evrolimus |
IHS |
R&D |
Enzalutamide |
IHS |
R&D |
Epirubicin |
USP/BP |
R&D |
Products |
Specification |
Document |
Fulvestrant |
USP/BP/IP |
R&D |
Efosfamide |
IHS |
R&D |
Granosetron |
IHS |
R&D |
Hydroxy Urea |
USP/BP/IP |
R&D |
Lapatinib |
IP |
R&D |
Leucovorin Calcium |
USP/IP |
R&D |
Pazopanib |
IHS |
R&D |
Pomalidomide |
IHS |
R&D |
Sorafenib |
IP |
R&D |
Sunitinib |
IHS |
R&D |
Tegafur & Uracil |
JP |
R&D |
Tamoxifen |
USP/BP/IP |
R&D |
Vincristine |
USP/BP/IP |
R&D |
Vinblastine |
USP/BP/IP |
R&D |
Zolendronic Acid |
IP |
R&D |
*T.P = Technical Package |
*BP = British Pharmacopeia |
*IHS = In-House Standard |
*IP = Indian Pharmacopeia |
*USP = United States Pharmacopeia |
|