Bioanalytical

Bioanalytical

Our team is committed to meet your critical study milestones with high quality data to facilitate your product development decisions. Our team has significant experience with small and large molecules using LC/MS/MS and ICP-OES equipment to support New Chemical Entities (NCE), biologic, biosimilar and generic drug development. We blend all our quality systems with efficient and validated processes to deliver high quality data on time.

  • Bioanalytical labs in India and Toronto, Canada.
  • Method library includes 275+ validated LC/MS/MS methods.
  • Dedicated method development group with international bioanalytical development experience.
  • 32 LC/MS/MS across our two laboratories.
Accelerated Analysis

We have a devoted team ready to meet study milestones and provide high quality data to facilitate product decisions. Our team has significant experience with small and large molecules using LC/MS/MS and ICP-OES equipment to support pharmaceutical time critical development and generic drug development with our Accelerated First-to-File (A-FTF) program. Cliantha blends all of our quality systems with efficient and validated processes to deliver high quality data on time.

Immunochemistry laboratory

Cliantha offers GLP compliant immunoassays. The bioanalytical services include GLP compliant assays for peptides, proteins, monoclonal antibodies (mAB) under FDA and EMA regulations. We utilize the following platforms:

  • ELISA
  • CMIA
  • Clot based assays
  • Flow cytometry

With our knowledge and experience comes the ability to work de novo, transfer and complete the development work for a client initiated assay and/or transfer a fully validated proprietary assay.

We have validated methods for
  • Levothyroxine and
  • Tri - iodo thyronine
  • Erythropoietin
  • Bevacizumab
  • Low molecular weight heparin (assessment of its pharmacodynamic parameters)
    • anti – factor IIa
    • anti – factor Xa
We have developed methods for
  • Rituximab
  • Teriparatide
  • Darbaepoeitin
  • Trastuzumab
  • GCSF
  • FSH
  • Peg GSF
Method Development and Validation

Our team has developed and validated for Cliantha more than 275 bioanalytical methods. Our scientists have the competency and experience to develop method in compliance with different international regulatory requirements. Our work has been submitted to the FDA, EMA, WHO, MCC, TGA, TPD for example. The methods are developed and validated using various traditional and state-of-art techniques.

Immunogenicity Testing

We are able to perform immunogenicity testing for antibodies to immunogenic drugs. We deploy a three tiered evaluation approach:

  • Anti-drug antibody screening test
  • Positive ADA confirmation test
  • Titration

Generally, floating cut points are used. Study specific cut points are calculated using baseline samples.

We have capabilities of detecting anti-drug antibodies by
  • Indirect / bridge ELISA
  • Confirmatory Assays using immuno-depletion
We have immunogenicity testing methods for
  • EPO
  • Bevacizumab
  • GCSF
Available Assays

Cliantha Research has analyzed in excess of 2 million samples in a variety of matrices. Our list of methods below is vast but it is not comprehensive. We may have additional matrices, ranges and new methods recently validated that have not made the list. Simply contact us to check if the assay is available.

List of Validated Methods
Analyte Matrix Sensitivity Method Status
17-Desacetyl Norgestimate (Norelgestromin)Human Plasma0.02 ng/mLLC/MS/MSValidated
2-pyridyl acetic acid (metabolite of Betahistine)Human Plasma5.0 ng/mLLC/MS/MSValidated
3-Keto Desogestrel Human Plasma50.0 pg/mL LC/MS/MSValidated
6-MNAHuman Plasma0.2 µg/mLLC/MS/MSValidated
Abacavir and LamivudineHuman Plasma0.1/0.05 µg/mLLC/MS/MSValidated
AbirateroneHuman Plasma0.2 ng/mLLC/MS/MSValidated
AbirateroneHuman Plasma1.0 ng/mLLC/MS/MSValidated
AcamprosateHuman Plasma1.0 ng/mLLC/MS/MSValidated
AcetaminophenHuman Plasma0.1 µg/mL LC/MS/MSValidated
AcetazolamideHuman Plasma0.03 µg/mLLC/MS/MSValidated
AcetazolamideHuman Plasma0.3 µg/mLLC/MS/MSValidated
AcyclovirHuman Plasma5.0 ng/mLLC/MS/MSValidated
AdalimumabHuman Serum110.0 ng/mLELISADeveloped
Adalimumab immunogenicity assayHuman Serum100 ng/mLELISADeveloped
AdiponectinHuman Serum0.1 ug/mLELISAValidated
AgomelatineHuman Plasma0.05 ng/mLLC/MS/MSValidated
Albendazole and Albendazole SulfoxideHuman Plasma0.25/2.5 ng/mLLC/MS/MSValidated
AlbuterolHuman Plasma10.0 pg/mLLC/MS/MSValidated
AlbuterolHuman Plasma0.2 ng/mLLC/MS/MSValidated
AlfuzosinHuman Plasma0.05 ng/mLLC/MS/MSValidated
AllopurinolHuman Plasma0.02 µg/mLLC/MS/MSValidated
AlmotriptanHuman Plasma0.5 ng/mLLC/MS/MSValidated
AlosetronHuman Plasma0.05 ng/mLLC/MS/MSValidated
AmantadineHuman Plasma2.0 ng/mLLC/MS/MSValidated
AmbrisentanHuman Plasma10.0 ng/mLLC/MS/MSValidated
AmilorideHuman Plasma0.1 ng/mLLC/MS/MSValidated
Amitriptyline and NortriptylineHuman Plasma0.12/0.04 ng/mLLC/MS/MSValidated
Amitriptyline and NortriptylineHuman Plasma0.02/0.01 ng/mLLC/MS/MSValidated
AmlodipineHuman Plasma0.1 ng/mLLC/MS/MSValidated
Amoxicillin and Clavulanic AcidHuman Plasma0.05/0.01 µg/mLLC/MS/MSValidated
Amoxicillin/Clavulanate AcidCat Plasma50/10 ng/mLLC/MS/MSUnder Development
AnastrozoleHuman Plasma0.2 ng/mLLC/MS/MSValidated
Anti-Heparin-PF4Human SerumNAELISAValidated
ApixabanHuman Plasma1.0 ng/mLLC/MS/MSValidated
ApremilastHuman Plasma2.0 ng/mLLC/MS/MSValidated
AripiprazoleHuman Plasma0.1 ng/mLLC/MS/MSValidated
AsenapineHuman Plasma0.05 ng/mLLC/MS/MSValidated
Asenapine and N-Desmethyl AsenapineHuman Plasma0.05/0.04 ng/mLLC/MS/MSValidated
AspirinHuman Plasma-LC/MS/MSUpcoming
Atazanavir Human Plasma20.0 ng/mLLC/MS/MSValidated
AtenololHuman Plasma5.0 ng/mLLC/MS/MSValidated
Atorvastatin, 2-Hydroxy Atorvastatin & 4-Hydroxy Atorvastatin Human Plasma0.25/0.25/0.05 ng/mLLC/MS/MSValidated
Atorvastatin, 2-Hydroxy Atorvastatin & 4-Hydroxy Atorvastatin Human Plasma0.25/0.25/0.025 ng/mLLC/MS/MSValidated
AtovaquoneHuman Plasma0.1 µg/mLLC/MS/MSValidated
AvanafilHuman Plasma0.01 µg/mLLC/MS/MSValidated
AzithromycinHuman Plasma5.0 ng/mLLC/MS/MSValidated
Baclofen Human Plasma10.0 ng/mLLC/MS/MSValidated
BalsalazideHuman Plasma1.0 ng/mLLC/MS/MSValidated
BevacizumabHuman Serum2.0 μg/mLELISAValidated
Bevacizumab immunogenicity assayHuman Serum124.0 ng/mLELISADeveloped
BosentanHuman Plasma10.0 ng/mLLC/MS/MSValidated
Brex Piprazole & DM-3411Human Plasma0.3/0.3 ng/mLLC/MS/MSValidated
BrexpiprazoleHuman Plasma0.3 ng/mLLC/MS/MSValidated
BudesonideHuman Plasma10.0 pg/mLLC/MS/MSValidated
BudesonideHuman Plasma25.0 pg/mLLC/MS/MSValidated
BudesonideHuman Plasma50.0 pg/mLLC/MS/MSValidated
BumetanideHuman Plasma0.3 ng/mLLC/MS/MSValidated
BuprenorphineHuman Plasma0.02 ng/mLLC/MS/MSValidated
Buprenorphine and NorbuprenorphineHuman Plasma0.02 ng/mL/0.02 ng/mLLC/MS/MSValidated
Bupropion, Hydroxy bupropion, Threo dihydrobupropion and Erythro dihydrobupropionHuman Plasma0.5/1.5/0.5/0.625 ng/mLLC/MS/MSValidated
Bupropion, Hydroxybupropion, Erythro-Dihydrobupropion, Threo-DihydrobupropionHuman Plasma2.0/10.0/2.0/10.0 ng/mLLC/MS/MSValidated
CalcitriolHuman Plasma10 pg/mLLC/MS/MSValidated
Calcitriol (Higher Range)Human Plasma10 pg/mLLC/MS/MSValidated
CanagliflozinHuman Plasma7.5 ng/mLLC/MS/MSValidated
CandesartanHuman Plasma1.0 ng/mLLC/MS/MSValidated
CandesartanHuman plasma0.2 ng/mLLC/MS/MSValidated
CapecitabineHuman Plasma10.0 ng/mLLC/MS/MSValidated
Carbamazepine and Carbamazepine 10, 11 epoxideHuman Plasma25.0/2.5 ng/mL LC/MS/MSValidated
CarbidopaHuman Plasma0.5 ng/mLLC/MS/MSValidated
CariprazineHuman Plasma-LC/MS/MSUpcoming
CarprofenDog Plasma0.1 µg/mLLC/MS/MSValidated
Cefpodoxime Dog Plasma0.375 µg/mLLC/MS/MSValidated
CeftriaxoneHuman Plasma3.0 µg/mLLC/MS/MSValidated
CelecoxibHuman Plasma10.0 ng/mLLC/MS/MSValidated
CevimelineHuman Plasma1.0 ng/mLLC/MS/MSValidated
Chlorpromazine & 7-Hydroxy ChlorpromazineHuman Plasma0.05/0.025 ng/mLLC/MS/MSValidated
Chlorpromazine & 7-Hydroxy ChlorpromazineHuman Plasma0.5/0.1 ng/mLLC/MS/MSValidated
Chlorpromazine and 7-OH ChlorpromazineHuman Plasma0.1/0.05 ng/mLLC/MS/MSValidated
ChlorthalidoneHuman Plasma5.0 ng/mLLC/MS/MSValidated
ChlorthalidoneHuman Plasma2.0 ng/mLLC/MS/MSValidated
CinacalcetHuman Plasma0.25 ng/mLLC/MS/MSValidated
Clarithromycin and 14-HydroxyclarithromycinHuman Plasma10.0/5.0 ng/mLLC/MS/MSValidated
Clobazam/N-DesmethylclobazamHuman Plasma2.5/1.0 ng/mLLC/MS/MSValidated
Clomipramine and N-Desmethyl ClomipramineHuman Plasma1.5/0.3 ng/mLLC/MS/MSValidated
Clomipramine and N-Desmethyl ClomipramineHuman Plasma0.25/0.05 ng/mLLC/MS/MSValidated
ClonidineHuman Plasma0.04 ng/mLLC/MS/MSValidated
ClonidineHuman Plasma5.0 pg/mLLC/MS/MSValidated
ClonidineHuman Plasma40.0 pg/mLLC/MS/MSValidated
Clopidogrel and Clopidogrel AcidHuman Plasma0.005/2.5 ng/mLLC/MS/MSValidated
ClozapineHuman Plasma2.0 ng/mLLC/MS/MSValidated
ColchicineHuman Plasma0.02 ng/mLLC/MS/MSValidated
CyclobenzaprineHuman Plasma0.2 ng/mL LC/MS/MSValidated
CycloserineHuman Plasma0.2 µg/mL LC/MS/MSValidated
CyclosporineDog Plasma-LC/MS/MSUpcoming
Cyproheptadine (Liquid-Liquid Method)Human Plasma0.05 ng/mLLC/MS/MSValidated
Cyproheptadine (Protein Precipitation Method)Human Plasma0.05 ng/mLLC/MS/MSValidated
Dabigatran (Free & Total)Human Plasma1.0/1.201 ng/mLLC/MS/MSValidated
DaclatasvirHuman Plasma5.0 ng/mLLC/MS/MSValidated
DalfampridineHuman Plasma0.2 ng/mLLC/MS/MSValidated
DapagliflozinHuman Plasma1.0 ng/mL LC/MS/MSValidated
DapsoneHuman Plasma0.05 ng/mLLC/MS/MSValidated
DapsoneHuman Plasma-LC/MS/MSUpcoming
DarunavirHuman Plasma0.025 µg/mLLC/MS/MSValidated
DeferasiroxHuman Plasma0.1 µg/mLLC/MS/MSValidated
DeracoxibDog Plasma5.0 ng/mLLC/MS/MSValidated
DesvenlafaxineHuman Plasma2.0 ng/mLLC/MS/MSValidated
DexamphetamineHuman Plasma0.5 ng/mLLC/MS/MSValidated
DexlansoprazoleHuman Plasma25.0 ng/mLLC/MS/MSValidated
DexmethylphenidateHuman Plasma0.1 ng/mLLC/MS/MSValidated
DextromethorphanHuman Plasma0.1 ng/mLLC/MS/MSValidated
DiclofenacHuman Plasma0.04 ng/mLLC/MS/MSValidated
DiclofenacHuman Plasma5 ng/mLLC/MS/MSValidated
Diclofenac/Esomeprazole (combined single method)Human Plasma5.0/2.5 ng/mLLC/MS/MSValidated
Dicyclomine (Dicycloverine)Human Plasma1.0 ng/mL LC/MS/MSValidated
DidanosineHuman Plasma10.0 ng/mLLC/MS/MSValidated
DienogestHuman Plasma0.5 ng/mL LC/MS/MSValidated
DiflunisalHuman Plasma1.0 µg/mLLC/MS/MSValidated
DigoxinHuman Plasma0.025 ng/mL LC/MS/MSValidated
Diltiazem, Desacetyl Diltiazem and N-Desmethyl DiltiazemHuman Plasma1.5 /0.3/0.3 ng/mLLC/MS/MSValidated
Diltiazem, Desacetyl Diltiazem and N-Desmethyl DiltiazemHuman Plasma0.6/0.12/0.21 ng/mLLC/MS/MSValidated
DipyridamoleHuman Plasma5.0 ng/mLLC/MS/MSValidated
DonepezilHuman Plasma0.1 ng/mLLC/MS/MSValidated
Donepezil and 6-O-Desmethyl DonepezilHuman Plasma0.1/0.02 ng/mLLC/MS/MSValidated
DoxazosinHuman Plasma0.1 ng/mLLC/MS/MSValidated
Doxepin and NordoxepinHuman Plasma15.0/5.0 pg/mLLC/MS/MSValidated
DoxorubicinHuman Plasma-LC/MS/MSUpcoming
DoxycyclineHuman Plasma0.02 µg/mLLC/MS/MSValidated
Dronedarone and Desbutyl DronedaroneHuman Plasma0.5/0.5 ng/mLLC/MS/MSValidated
DrospirenoneHuman Plasma0.5 ng/mLLC/MS/MSValidated
DrotaverineHuman Plasma-LC/MS/MSUpcoming
DroxidopaHuman Plasma5.5 ng/mL LC/MS/MSValidated
DuloxetineHuman Plasma0.2 ng/mLLC/MS/MSValidated
DutasterideHuman Plasma0.05 ng/mLLC/MS/MSValidated
EdoxabanHuman Plasma-LC/MS/MSUpcoming
EletriptanHuman Plasma0.5 ng/mLLC/MS/MSValidated
EmpagliflozinHuman Plasma1.0 ng/mL LC/MS/MSValidated
EmtricitabineHuman Plasma5.0 ng/mLLC/MS/MSValidated
Enalapril and EnalaprilatHuman Plasma0.5/0.5 ng/mLLC/MS/MSValidated
Enoxaparin Sodium Anti Factor IIaHuman Plasma0.030 IU/mLChromogenicValidated
Enoxaparin Sodium Anti Factor Xa (Chromogenic assay)Human Plasma0.050 IU/mLChromogenicValidated
Enoxaparin sodium Anti Factor Xa (Clotting assay)Human Plasma0.075 IU/mLClot basedValidated
EnrofloxacinDog Plasma10.0 ng/mLLC/MS/MSValidated
EnrofloxacinCat Plasma10.0 ng/mLLC/MS/MSValidated
EntecavirHuman Plasma0.04 ng/mLLC/MS/MSValidated
EnzalutamideHuman Plasma0.05 µg/mLLC/MS/MSValidated
EnzalutamideHuman Plasma0.10 µg/mLLC/MS/MSValidated
EplerenoneHuman Plasma0.010 µg/mLLC/MS/MSValidated
ErlotinibHuman Plasma5.0 ng/mLLC/MS/MSValidated
ErythromycinHuman Plasma10.0 ng/mLLC/MS/MSValidated
ErythropoietinHuman Serum3.5 mIU/mLELISAValidated
Erythropoietin Immunogenicity assayHuman Serum248.48 ng/mLELISAValidated
EscitalopramHuman Plasma0.2 ng/mLLC/MS/MSValidated
EsomeprazoleHuman Plasma4.0 ng/mLLC/MS/MSValidated
EtanerceptHuman Serum100 ng/mLELISADeveloped
Ethacrynic acidHuman Plasma2.0 ng/mLLC/MS/MSValidated
Ethinyl EstradiolHuman Plasma1.0 pg/mLLC/MS/MSValidated
Ethyl Hydrogen FumarateHuman Plasma-LC/MS/MSUpcoming
EtodolacHuman Plasma0.1 µg/mLLC/MS/MSValidated
ExemestaneHuman Plasma0.1 ng/mLLC/MS/MSValidated
ExemestaneHuman Plasma0.2 ng/mLLC/MS/MSValidated
Ezetimibe and Ezetimibe GlucuronideHuman Plasma0.025/0.25 ng/mLLC/MS/MSValidated
FamotidineHuman Plasma1.0 ng/mLLC/MS/MSValidated
FebuxostatHuman Plasma0.02 µg/mLLC/MS/MSValidated
FelbamateHuman Plasma0.4 µg/mLLC/MS/MSValidated
Fenofibric AcidHuman Plasma0.05 µg/mLLC/MS/MSValidated
FentanylHuman Plasma2.0 pg/mLLC/MS/MSValidated
FinasterideHuman Plasma0.1 ng/mLLC/MS/MSValidated
FlecainideHuman Plasma1.0 ng/mLLC/MS/MSValidated
FluconazoleHuman Plasma0.1 µg/mLLC/MS/MSValidated
FluconazoleHuman Plasma0.025 µg/mLLC/MS/MSValidated
FlucytosinHuman Plasma0.05 µg/mLLC/MS/MSValidated
FlunarizineHuman Plasma0.2 ng/mLLC/MS/MSValidated
FluoxetineHuman Plasma0.2 ng/mLLC/MS/MSValidated
Fluoxetine and NorfluoxetineHuman Plasma0.5/0.5 ng/mLLC/MS/MSValidated
Flupirtine and Acetylated FlupirtineHuman Plasma8.0/2.0 ng/mLLC/MS/MSValidated
Follicle stimulating hormone (FSH)Human Serum30.0 pg/mLCMIAValidated
Fosfomycin Human Plasma0.5 ng/mLLC/MS/MSUnder Development
FosinoprilatHuman Plasma5.0 ng/mLLC/MS/MSValidated
FurosemideHuman Plasma10.0 ng/mLLC/MS/MSValidated
GabapentinHuman Plasma20.0 ng/mLLC/MS/MSValidated
GCSFHuman Serum250.0 pg/mLELISADeveloped
GCSF immunogenicity assayHuman Serum-ELISADeveloped
GestodeneHuman Plasma0.05 ng/mLLC/MS/MSValidated
GliclazideHuman Plasma0.01 µg/mLLC/MS/MSValidated
GlipizideHuman Plasma3.0 ng/mLLC/MS/MSValidated
GlucoseHuman Serum25 mg/dLChromogenic (GOD-POD)Developed
GlyburideHuman Plasma1.0 ng/mLLC/MS/MSValidated
GranisetronHuman Plasma0.02 ng/mLLC/MS/MSValidated
GrhelinHuman Serum46.875 pg/mLELISAValidated
Growth HormoneHuman Serum75.0 pg/mLELISAValidated
GuaifenesinHuman Plasma20.0 ng/mLLC/MS/MSValidated
GuanfacineHuman Plasma0.05 ng/mLLC/MS/MSValidated
Hemolytic potential of drugHuman blood-ChromogenicValidated
Hep test (LMWH by Anti-Xa) Human Plasma0.075 IU/mLClot basedValidated
Her2 Human Serum78.1 pg/mLELISAUnder Development
Hydrochlorothiazide Human Plasma0.5 ng/mLLC/MS/MSValidated
HydrocortisoneHuman Plasma4.0 ng /mLLC/MS/MSValidated
HydromorphoneHuman Plasma0.05 ng/mLLC/MS/MSValidated
Hydroxyzine and CetirizineHuman Plasma0.4/1.4 ng/mLLC/MS/MSValidated
IbrutinibHuman Plasma0.4 ng/mLLC/MS/MSValidated
IbrutinibHuman Plasma10.0 ng/mLLC/MS/MSUnder Development
IbuprofenHuman Plasma0.05 µg/mLLC/MS/MSValidated
IbuprofenHuman Plasma0.2 µg/mL LC/MS/MSValidated
ImatinibHuman Plasma0.05 µg/mLLC/MS/MSValidated
ImatinibHuman Plasma10.0 ng/mLLC/MS/MSValidated
Imipramine and DesipramineHuman Plasma0.5/0.25 ng/mLLC/MS/MSValidated
Immunoglobulin A (IgA)Human Serum0.6 g/LTurbidimetricValidated
Immunoglobulin G (IgG)Human Serum3.0 g/LTurbidimetricValidated
Immunoglobulin M (IgM)Human Serum0.4 g/LTurbidimetricValidated
IndapamideHuman Blood2.0 ng/mLLC/MS/MSValidated
Insulin Like Growth Factor-I (IGF-I)Human Serum0.094 ng/mLELISAValidated
IrbesartanHuman Plasma5.0 ng/mLLC/MS/MSValidated
Isosorbide Dinitrate and HydralazineHuman Plasma-LC/MS/MSUpcoming
Isosorbide Dinitrate, Isosorbide-5-Mononitrate, Isosorbide-2-MononitrateHuman Plasma4.0/4.0/4.0 ng/mLLC/MS/MSValidated
Isosorbide MononitrateHuman Plasma10.0 ng/mLLC/MS/MSValidated
IsotretinoinHuman Plasma0.6 ng/mLLC/MS/MSUnder Development
Itraconazole and Hydroxy ItraconazoleHuman Plasma1.0/2.0 ng/mLLC/MS/MSValidated
Ivabradine and N-Desmethyl Ivabradine Human Plasma1.0/0.1 ng/mLLC/MS/MSValidated
LacosamideHuman Plasma0.01 µg/mLLC/MS/MSValidated
Lamivudine, Zidovudine and AbacavirHuman Plasma20.0/20.0/40.0 ng/mL LC/MS/MSValidated
LamotrigineHuman Plasma10.0 ng/mLLC/MS/MSValidated
LamotrigineHuman Plasma0.04 µg/mLLC/MS/MSValidated
LansoprazoleHuman Plasma2.0 ng/mLLC/MS/MSValidated
LedipasvirHuman Plasma3.0 ng/mLLC/MS/MSValidated
LenalidomideHuman Plasma2.0 ng/mLLC/MS/MSValidated
LeptinHuman Serum2.0 ng/mLELISAValidated
LevetiracetamHuman Plasma0.3 µg/mLLC/MS/MSValidated
Levodopa and CarbidopaHuman Plasma10.0/2.0 ng/mLLC/MS/MSValidated
Levodopa and CarbidopaHuman Plasma10.0/0.5 ng/mLLC/MS/MSValidated
Levodopa and CarbidopaHuman Plasma10.0/1.0 ng/mLLC/MS/MSValidated
LevofloxacinHuman Plasma0.05 µg/mLLC/MS/MSValidated
LevomefolateHuman Plasma3.0 ng/mLLC/MS/MSValidated
Levomilnacipran Human Plasma1.0 ng/mLLC/MS/MSValidated
LevonorgestrelHuman Plasma0.1 ng/mLLC/MS/MSValidated
LevothyroxineHuman Serum35.0 ng/mLLC/MS/MSValidated
LevothyroxineHuman Serum3.5 μg/dLELISAValidated
LidocaineHuman Plasma0.2 ng/mLLC/MS/MSValidated
LinaclotideHuman Plasma-LC/MS/MSUpcoming
LinagliptineHuman Plasma0.1 ng/mLLC/MS/MSValidated
Lio thyronineHuman Serum0.5 ng/mLELISAValidated
LisinoprilHuman Plasma1.0 ng/mLLC/MS/MSValidated
LMWH Anti Factor IIaHuman Plasma0.030 IU/mLChromogenicValidated
LMWH Anti Factor IIa (Chromogenic assay) - EUHuman Plasma0.030 IU/mLChromogenicValidated
LMWH Anti Factor XaHuman Plasma0.050 IU/mLChromogenicValidated
LMWH Anti Factor Xa (Chromogenic assay) - EUHuman Plasma0.050 IU/mLChromogenicValidated
LMWH for APTTHuman PlasmaNAClot basedValidated
LMWH for APTT -EUHuman PlasmaNAClot basedValidated
LMWH HEP Test - EUHuman Plasma0.1 IU/mLClot basedValidated
Loratadine and DescarboethoxyloratadineHuman Plasma0.02/0.02 ng/mL LC/MS/MSValidated
LorcaserinHuman Plasma0.5 ng/mLLC/MS/MSValidated
LurasidoneHuman Plasma0.2 ng/mLLC/MS/MSValidated
MacitentanHuman Plasma1.0 ng/mLLC/MS/MSValidated
Marbofloxacin Dog Plasma5 ng/mLLC/MS/MSValidated
Marbofloxacin Cat Plasma5 ng/mLLC/MS/MSValidated
MebendazoleHuman Plasma0.1 ng/mLLC/MS/MSValidated
Medroxyprogesterone acetateHuman Plasma0.025 ng/mL LC/MS/MSValidated
MeloxicamDog Plasma5.0 ng/mLLC/MS/MSValidated
MeloxicamHuman Plasma5.0 ng/mLLC/MS/MSValidated
MemantineHuman Plasma0.1 ng/mLLC/MS/MSValidated
MercaptopurineHuman Plasma-LC/MS/MSUnder Development
MesalamineHuman Plasma4.0 ng/mLLC/MS/MSValidated
MesalamineHuman Plasma2.0 ng/mLLC/MS/MSValidated
MetaxaloneHuman Plasma25.0 ng/mLLC/MS/MSValidated
MetforminHuman Plasma10.0 ng/mLLC/MS/MSValidated
MethenamineHuman Plasma0.25 µg/mLLC/MS/MSValidated
MethotrexateHuman Plasma3.0 ng/mLLC/MS/MSValidated
MethylergonovineHuman Plasma0.5 ng/mLLC/MS/MSValidated
MethylphenidateHuman Plasma0.1 ng/mLLC/MS/MSValidated
MethylprednisoloneHuman Plasma1.0 ng/mLLC/MS/MSValidated
MetoclopramideHuman Plasma0.25 ng/mLLC/MS/MSValidated
MetolazoneHuman Plasma0.25 ng/mLLC/MS/MSValidated
MetoprololHuman Plasma0.3 ng/mLLC/MS/MSValidated
MetronidazoleHuman Plasma2.0 ng/mLLC/MS/MSValidated
MetronidazoleHuman Plasma0.2 µg/mLLC/MS/MSValidated
MidodrineHuman Plasma0.2 ng/mLLC/MS/MSValidated
Milbemycin OximeDog Plasma-LC/MS/MSUpcoming
MinocyclineHuman Plasma20.0 ng/mL LC/MS/MSValidated
MirabegronHuman Plasma0.2 ng/mLLC/MS/MSValidated
MirtazapineHuman Plasma0.25 ng/mLLC/MS/MSValidated
MisoprostolHuman Plasma7.5 pg/mLLC/MS/MSValidated
ModafinilHuman Plasma0.05 µg/mLLC/MS/MSValidated
Monomethyl FumarateHuman Plasma0.02 µg/mLLC/MS/MSValidated
MonteleukastHuman Plasma2.0 ng/mLLC/MS/MSValidated
MontelukastHuman Plasma-LC/MS/MSUnder Development
NadololHuman Plasma1.0 ng/mLLC/MS/MSValidated
NaproxenHuman Plasma0.2 µg/mLLC/MS/MSValidated
NateglinideHuman Plasma0.05 µg/mLLC/MS/MSValidated
NCE-1Human Plasma0.2 ng/mLLC/MS/MSValidated
NCE-1 MetaboliteHuman Plasma0.1 ng/mLLC/MS/MSValidated
NCE-2Human Plasma-LC/MS/MSUpcoming
NebivololHuman Plasma0.04 ng/mLLC/MS/MSValidated
NevirapineHuman Plasma0.03 µg/mLLC/MS/MSValidated
Niacin and Nicotinuric AcidHuman Plasma5.0/2.5 ng/mLLC/MS/MSValidated
NifedipineHuman Plasma0.5 ng/mLLC/MS/MSValidated
NintedanibHuman Plasma0.3 ng/mLLC/MS/MSValidated
NitisinoneHuman Plasma10 ng/mLLC/MS/MSUnder Development
NitrofurantoinHuman Plasma5.0 ng/mLLC/MS/MSValidated
Nitrofurantoin Human Plasma1.0 ng/mLLC/MS/MSValidated
NorethindroneHuman Plasma0.1 ng/mLLC/MS/MSValidated
NorethindroneHuman Plasma0.2 ng/mLLC/MS/MSValidated
Norgestimate and 17-Desacetyl norgestimate Human Plasma2.0/36.0 pg/mLLC/MS/MSValidated
Nortriptyline and 10-Hydroxy NortriptylineHuman Plasma0.2/0.4 ng/mLLC/MS/MSValidated
OlmesartanHuman Plasma10.0 ng/mLLC/MS/MSValidated
OlopatadineHuman Plasma0.05 ng/mLLC/MS/MSValidated
OmeprazoleHuman Plasma2.0 ng/mLLC/MS/MSValidated
Omeprazole Human Plasma5.0 ng/mL LC/MS/MSValidated
Oseltamivir and Oseltamivir Carboxylic Acid Human Plasma0.5/5.0 ng/mLLC/MS/MSValidated
OspemifeneHuman Serum3.0 ng/mLLC/MS/MSValidated
Oxcarbazepine and 10,11-dihydro-10-hydroxy-carbamazepineHuman Plasma0.02/0.07 µg/mLLC/MS/MSValidated
Oxybutynin and Desethyl oxybutyninHuman Plasma0.05/0.2 ng/mLLC/MS/MSValidated
Oxybutynin and N-Desethyl Oxybutynin Human Plasma0.15/0.3 ng/mLLC/MS/MSValidated
OxycodoneHuman Plasma0.2 ng/mLLC/MS/MSUnder Development
PalbociclibHuman Plasma-LC/MS/MSUnder Development
PaliperidoneHuman Plasma0.2 ng/mLLC/MS/MSValidated
PantoprazoleHuman Plasma2.0 ng/mLLC/MS/MSValidated
ParampanelHuman Plasma1.0 ng/mL LC/MS/MSValidated
ParoxetineHuman Plasma0.2 ng/mLLC/MS/MSValidated
Peg-GCSFHuman Serum250.0 pg/mLELISAUnder Development
Perindopril / PerindoprilatHuman Plasma0.5/0.2 ng/mLLC/MS/MSValidated
Perindopril and PerindoprilatHuman Plasma0.5/0.2 ng/mLLC/MS/MSValidated
PerphenazineHuman Plasma0.015 ng/mLLC/MS/MSValidated
PhenazopyridineHuman Plasma0.2 ng/mLLC/MS/MSValidated
PimobendanDog Plasma1.0 ng/mLLC/MS/MSValidated
PindololHuman Plasma1.0 ng/mLLC/MS/MSValidated
Pioglitazone, Hydroxy pioglitazone and Keto pioglitazoneHuman Plasma5.0/2.5/2.5 ng/mLLC/MS/MSValidated
PirfenidoneHuman Plasma-LC/MS/MSUpcoming
PitavastatinHuman Plasma0.2 ng/mLLC/MS/MSValidated
PomalidomideHuman Plasma0.2 ng/mLLC/MS/MSValidated
PosaconazoleHuman Plasma2.0 ng/mLLC/MS/MSValidated
PotassiumHuman Urine100.0 µg/mLICP-OESValidated
PramipexoleHuman Plasma25.0 pg/mLLC/MS/MSValidated
PramipexoleHuman Plasma-LC/MS/MSUnder Development
Prasugrel active metabolite (R138727)Human Plasma0.2 ng/mLLC/MS/MSValidated
Prasugrel inactive metabolite (R95913)Human Plasma0.25 ng/mLLC/MS/MSValidated
PrazosinHuman Plasma0.2 ng/mLLC/MS/MSValidated
Prednisone and prednisoloneHuman Plasma0.2/2.0 ng/mLLC/MS/MSValidated
PregabalinHuman Plasma0.05 µg/mLLC/MS/MSValidated
ProgesteroneHuman Plasma0.5 ng/mLLC/MS/MSValidated
ProgesteroneHuman Plasma0.05 ng/mLLC/MS/MSValidated
PromethazineHuman Plasma0.5 ng/mLLC/MS/MSValidated
Propafenone and 5-Hydroxy PropafenoneHuman Plasma0.2/0.1 ng/mLLC/MS/MSValidated
Propafenone and 5-Hydroxy PropafenoneHuman Plasma0.075/0.15 ng/mLLC/MS/MSValidated
Propranolol and 4-Hydroxy Propranolol (Total)Human Plasma0.9955/0.7875 ng/mLLC/MS/MSValidated
PyridostigmineHuman Plasma0.75 ng/mLLC/MS/MSValidated
QuetiapineHuman Plasma1.0 ng/mLLC/MS/MSValidated
RabeprazoleHuman Plasma2.0 ng/mLLC/MS/MSValidated
Raloxifene, Raloxifene 4 glucuronide and Raloxifene 6 glucuronideHuman Plasma0.01/4.0/0.8 ng/mLLC/MS/MSValidated
Ramipril and RamiprilatHuman Plasma0.1/0.1 ng/mLLC/MS/MSValidated
RanitidineHuman Plasma10 ng/mLLC/MS/MSValidated
RanolazineHuman Plasma5.0 ng/mLLC/MS/MSValidated
RasagilineHuman Plasma0.01 ng/mLLC/MS/MSValidated
RepaglinideHuman Plasma0.2 ng/mLLC/MS/MSValidated
RibavirinHuman Plasma20.0 ng/mLLC/MS/MSValidated
RifabutinHuman Plasma2 ng/mLLC/MS/MSValidated
RituximabHuman Serum1.5 μg/mLELISADeveloped
Rituximab immunogenicity assayHuman Serum-ELISAUnder Development
RivaroxabanHuman Plasma-LC/MS/MSUpcoming
RivastigmineHuman Plasma50.0 pg/mLLC/MS/MSValidated
RivastigmineHuman Plasma0.05 ng/mLLC/MS/MSValidated
RizatriptanHuman Plasma0.2 ng/mLLC/MS/MSValidated
Rosuvastatin and N-Desmethyl RosuvastatinHuman Plasma0.1/0.4 ng/mLLC/MS/MSValidated
RufinamideHuman Plasma20.0 ng/mLLC/MS/MSUnder Development
S-(+)-Manidipine and R-(-)-ManidipineHuman Plasma0.05 (R)/0.05(S) ng/mLLC/MS/MSValidated
SacubritilHuman Plasma10.0 ng/mLLC/MS/MSValidated
SalsalateHuman Plasma0.125 µg/mLLC/MS/MSValidated
ScopolamineHuman Plasma1.0 pg/mLLC/MS/MSUnder Development
Sertraline and N-DesmethylsertralineHuman Plasma0.5/0.5 ng/mLLC/MS/MSValidated
SildenafilHuman Plasma1.0 ng/mLLC/MS/MSValidated
Silodosin and Silodosin GlucuronideHuman Plasma0.2/0.3 ng/mLLC/MS/MSValidated
SirolimusHuman Blood0.15 ng/mLLC/MS/MSValidated
SitagliptinHuman Plasma2.0 ng/mLLC/MS/MSValidated
Sofosbuvir and Sofosbuvir metabolite GS331007 Human Plasma5.0/5.0 ng/mLLC/MS/MSValidated
SolifenacinHuman Plasma0.1 ng/mLLC/MS/MSValidated
SpironolactoneHuman Plasma0.5 ng/mLLC/MS/MSValidated
TacrolimusWhole Blood0.2 ng/mLLC/MS/MSValidated
TadalafilHuman Plasma2.0 ng/mLLC/MS/MSValidated
TamoxifenHuman Plasma0.5 ng/mLLC/MS/MSValidated
TamsulosinHuman Plasma0.2 ng/mLLC/MS/MSValidated
TelmisartanHuman Plasma0.5 ng/mLLC/MS/MSValidated
TeneligliptinHuman Plasma1.0 ng/mLLC/MS/MSValidated
TenofovirHuman Plasma3.0 ng/mL LC/MS/MSValidated
TeriflunamideHuman Plasma0.02 µg/mLLC/MS/MSValidated
TeriparatideHuman Plasma20.0 pg/mLELISADeveloped
TestosteroneHuman Serum0.05 ng/mLLC/MS/MSValidated
Tetrabenazine and Hydroxy TetrabenazineHuman Plasma0.005/0.5 ng/mLLC/MS/MSValidated
ThiothixeneHuman Plasma0.05 ng/mLLC/MS/MSValidated
TiotropiumHuman Plasma0.2 pg/mLLC/MS/MSValidated
Tissue factor pathway inhibitor (TFPI)Human Plasma31.25 ng/mLELISAValidated
TizanidineHuman Plasma0.05 ng/mLLC/MS/MSValidated
TizanidineHuman Plasma0.1 ng/mLLC/MS/MSValidated
Tofacitinib Human Plasma0.5 ng/mLLC/MS/MSValidated
Tolterodine and 5-Hydroxy methyl tolterodineHuman Plasma0.02/0.02 ng/mLLC/MS/MSValidated
TolvaptanHuman Plasma 0.5 ng/mL LC/MS/MSValidated
TopiramateHuman Plasma2.0 ng/mLLC/MS/MSValidated
Topiramate Human Plasma50.0 ng/mLLC/MS/MSValidated
ToremifeneHuman Plasma-LC/MS/MSUpcoming
TramadolHuman Plasma1.0 ng/mLLC/MS/MSValidated
Tramadol and O-DesmethyltramadolHuman Plasma1.0/0.5 ng/mLLC/MS/MSValidated
Trandolapril and TrandolaprilatHuman Plasma0.05/0.1 ng/mLLC/MS/MSValidated
TrastuzumabHuman Serum2.0 ug/mLELISADeveloped
Trastuzumab immunogenicity assayHuman Serum100 ng/mLELISADeveloped
Trazodone and M-CPPHuman Plasma10.0/0.5 ng/mLLC/MS/MSValidated
Triamcinolone AcetonideHuman Plasma0.05 ng/mL LC/MS/MSValidated
TriamtereneHuman Plasma3.0 ng/mLLC/MS/MSValidated
Triamterene and HydrochlorothiazideHuman Plasma2.0/0.5 ng/mLLC/MS/MSValidated
TriazolamHuman Plasma0.1 ng/mLLC/MS/MSValidated
Trientine / N1-Acetyl TrientineHuman Plasma10/2.5 ng/mLLC/MS/MSValidated
TrimetazidineHuman Plasma0.5 ng/mLLC/MS/MSValidated
TrospiumHuman Plasma0.04 ng/mL LC/MS/MSValidated
Ulipristal acetateHuman Plasma0.1 ng/mLLC/MS/MSUnder Development
Ursodiol, Glycoursodeoxycholic acid (GUDCA) and Tauroursodeoxycholic acid (TUDCA)Human Plasma0.07/0.07/0.007 µg/mLLC/MS/MSValidated
Valacylovir and AcyclovirHuman Plasma3.0/40.0 ng/mLLC/MS/MSValidated
Valproic acidHuman Plasma0.5 µg/mLLC/MS/MSValidated
ValsartanHuman Plasma0.01 µg/mLLC/MS/MSValidated
VancomycinHuman Plasma0.5 µg/mLLC/MS/MSValidated
VardenafilHuman Plasma0.125 ng/mLLC/MS/MSValidated
Venlafaxine and O-DesmethylvenlafaxineHuman Plasma2.0/2.0 ng/mLLC/MS/MSValidated
Verapamil and NorverapamilHuman Plasma1.0/1.0 ng/mLLC/MS/MSValidated
VilazodoneHuman Plasma0.1 ng/mLLC/MS/MSValidated
VildagliptinHuman Plasma2.0 ng/mLLC/MS/MSValidated
VoriconazoleHuman Plasma10.0 ng/mL LC/MS/MSValidated
VortioxetineHuman Plasma0.05 ng/mLLC/MS/MSValidated
WarfarinHuman Plasma10.0 ng/mLLC/MS/MSValidated
ZafirlukastHuman Plasma5.0 ng/mLLC/MS/MSValidated
Zidovudine and LamivudineHuman Plasma6.0/6.0 ng/mLLC/MS/MSValidated
ZileutonHuman Plasma0.03 µg/mLLC/MS/MSValidated
ZiprasidoneHuman Plasma0.5 ng/mLLC/MS/MSValidated
Zolmitriptan and N-Desmethyl zolmitriptanHuman Plasma0.1/0.075 ng/mLLC/MS/MSValidated
ZolpidemHuman Plasma1.0 ng/mL LC/MS/MSValidated

Regulatory Inspections

Goverment of India Facilities inspected & approved by Drugs Controller General of India
Last inspection in Nov 2015 by
Austria (2 times)
Inspected facility in Nov 2006 by
ANSM
Inspection facility in jan 2009 by
MCC
Last inspection in March 2017 by
USFDA (17 times)
Last inspection in April 2017 by
UK MHRA (2 times)
Last inspection in March 2013 by
WHO (3 times)
Inspected facility in July 2013 by
Thai MOH
Last inspected by Ministry of Health of Turkey in April 2013
Inspected facility in April 2011 by
Spain