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 Plasma 0.02 ng/mL LC/MS/MS Validated
2-pyridyl acetic acid (metabolite of Betahistine) Human Plasma 5.0 ng/mL LC/MS/MS Validated
3-Keto Desogestrel Human Plasma 50.0 pg/mL LC/MS/MS Validated
6-MNA Human Plasma 0.2 µg/mL LC/MS/MS Validated
Abacavir and Lamivudine Human Plasma 0.1/0.05 µg/mL LC/MS/MS Validated
Abiraterone Human Plasma 0.2 ng/mL LC/MS/MS Validated
Abiraterone Human Plasma 1.0 ng/mL LC/MS/MS Validated
Abiraterone Human Plasma - LC/MS/MS Upcoming
Acamprosate Human Plasma 1.000 ng/mL LC/MS/MS Validated
Acetaminophen Human Plasma 0.1 µg/mL LC/MS/MS Validated
Acetazolamide Human Plasma 0.03 µg/mL LC/MS/MS Validated
Acetazolamide Human Plasma 0.3 µg/mL LC/MS/MS Validated
Acyclovir Human Plasma 5.0 ng/mL LC/MS/MS Validated
Adalimumab Human Serum 110.0 ng/mL ELISA Under Development
Adalimumab immunogenicity assay Human Serum - ELISA Under Development
Agomelatine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Albendazole and Albendazole Sulfoxide Human Plasma 0.25/2.5 ng/mL LC/MS/MS Validated
Albuterol Human Plasma 10.0 pg/mL LC/MS/MS Validated
Albuterol Human Plasma 0.2 ng/mL LC/MS/MS Validated
Alfuzosin Human Plasma 0.05 ng/mL LC/MS/MS Validated
Allopurinol Human Plasma 0.02 µg/mL LC/MS/MS Validated
Almotriptan Human Plasma 0.5 ng/mL LC/MS/MS Validated
Alosetron Human Plasma 0.05 ng/mL LC/MS/MS Validated
Amantadine Human Plasma 2.0 ng/mL LC/MS/MS Validated
Ambrisentan Human Plasma 10.0 ng/mL LC/MS/MS Validated
Amiloride Human Plasma 0.1 ng/mL LC/MS/MS Validated
Amitriptyline and Nortriptyline Human Plasma 0.12/0.04 ng/mL LC/MS/MS Validated
Amitriptyline and Nortriptyline Human Plasma 0.02/0.01 ng/mL LC/MS/MS Validated
Amlodipine Human Plasma 0.1 ng/mL LC/MS/MS Validated
Amoxicillin and Clavulanic Acid Human Plasma 0.05/0.01 µg/mL LC/MS/MS Validated
Anastrozole Human Plasma 0.2 ng/mL LC/MS/MS Validated
Apixaban Human Plasma 1.0 ng/mL LC/MS/MS Validated
Apremilast Human Plasma 2.0 ng/mL LC/MS/MS Validated
Aripiprazole Human Plasma 0.1 ng/mL LC/MS/MS Validated
Asenapine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Asenapine Human Plasma - LC/MS/MS Under Development
Asenapine and N-Desmethyl Asenapine Human Plasma 0.05/0.04 ng/mL LC/MS/MS Validated
Atazanavir Human Plasma 20.0 ng/mL LC/MS/MS Validated
Atenolol Human Plasma 5.0 ng/mL LC/MS/MS Validated
Atorvastatin, 2-Hydroxy Atorvastatin and 4-Hydroxy Atorvastatin Human Plasma 0.25/0.25/0.05 ng/mL LC/MS/MS Validated
Atorvastatin, 2-Hydroxy Atorvastatin and 4-Hydroxy Atorvastatin Human Plasma 0.25/0.25/0.025 ng/mL LC/MS/MS Validated
Atovaquone Human Plasma 0.1 µg/mL LC/MS/MS Validated
Avanafil Human Plasma 0.01 µg/mL LC/MS/MS Validated
Azithromycin Human Plasma 5.0 ng/mL LC/MS/MS Validated
Baclofen Human Plasma 10.0 ng/mL LC/MS/MS Validated
Balsalazide Human Plasma 1.0 ng/mL LC/MS/MS Validated
Bevacizumab Human Serum 2.0 μg/mL ELISA Validated
Bevacizumab immunogenicity assay Human Serum 124.0 ng/mL ELISA Developed
Bosentan Human Plasma 10.0 ng/mL LC/MS/MS Validated
Brex Piprazole & Metabolite Human Plasma - LC/MS/MS Under Development
Budesonide Human Plasma 10.0 pg/mL LC/MS/MS Validated
Budesonide Human Plasma 25.0 pg/mL LC/MS/MS Validated
Budesonide Human Plasma 50.0 pg/mL LC/MS/MS Validated
Bumetanide Human Plasma 0.3 ng/mL LC/MS/MS Validated
Buprenorphine Human Plasma 0.02 ng/mL LC/MS/MS Validated
Buprenorphine and Norbuprenorphine Human Plasma 0.02 ng/mL/0.02 ng/mL LC/MS/MS Validated
"Bupropion, Hydroxy bupropion, Threo dihydrobupropion and Erythro dihydrobupropion" Human Plasma 0.5/1.5/0.5/0.625 ng/mL LC/MS/MS Validated
Calcitriol Human Plasma 10 pg/mL LC/MS/MS Validated
Canagliflozin Human Plasma 7.5 ng/mL LC/MS/MS Validated
Candesartan Human Plasma 1.0 ng/mL LC/MS/MS Validated
Candesartan Human plasma 0.2 ng/mL LC/MS/MS Validated
Capecitabine Human Plasma 10.0 ng/mL LC/MS/MS Validated
Carbamazepine and Carbamazepine 10, 11 epoxide Human Plasma 25.0/2.5 ng/mL LC/MS/MS Validated
Carbidopa Human Plasma 0.5 ng/mL LC/MS/MS Validated
Carprofen Dog Plasma 0.1 µg/mL LC/MS/MS Validated
Cefpodoxime Dog Plasma 0.375 µg/mL LC/MS/MS Validated
Ceftriaxone Human Plasma 3.0 µg/mL LC/MS/MS Validated
Celecoxib Human Plasma 10.0 ng/mL LC/MS/MS Validated
Cevimeline Human Plasma 1.0 ng/mL LC/MS/MS Validated
Chlorpromazine and 7-OH Chlorpromazine Human Plasma 0.1/0.05 ng/mL LC/MS/MS Validated
Chlorthalidone Human Plasma 5.0 ng/mL LC/MS/MS Validated
Chlorthalidone Human Plasma 2.0 ng/mL LC/MS/MS Validated
Cinacalcet Human Plasma 0.25 ng/mL LC/MS/MS Validated
Clarithromycin and 14-Hydroxyclarithromycin Human Plasma 10.0/5.0 ng/mL LC/MS/MS Validated
Clobazam/N-Desmethylclobazam Human Plasma 2.5/1.0 ng/mL LC/MS/MS Validated
Clomiphene Human Plasma - LC/MS/MS Under Development
Clomipramine and N-Desmethyl Clomipramine Human Plasma 1.5/0.3 ng/mL LC/MS/MS Validated
Clomipramine and N-Desmethyl Clomipramine Human Plasma 0.25/0.05 ng/mL LC/MS/MS Validated
Clonidine Human Plasma 0.04 ng/mL LC/MS/MS Validated
Clonidine Human Plasma 5.0 pg/mL LC/MS/MS Validated
Clopidogrel and Clopidogrel Acid Human Plasma 0.005/2.5 ng/mL LC/MS/MS Validated
Clozapine Human Plasma 2.0 ng/mL LC/MS/MS Validated
Colchicine Human Plasma 0.02 ng/mL LC/MS/MS Validated
Cyclobenzaprine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Cycloserine Human Plasma 0.2 µg/mL LC/MS/MS Validated
Cyproheptadine (Liquid-Liquid Method) Human Plasma 0.05 ng/mL LC/MS/MS Validated
Cyproheptadine (Protein Precipitation Method) Human Plasma 0.05 ng/mL LC/MS/MS Validated
Dabigatran (Free & Total) Human Plasma 1.0/1.201 ng/mL LC/MS/MS Validated
Daclatasvir Human Plasma 5.0 ng/mL LC/MS/MS Validated
Dapagliflozin Human Plasma 1.0 ng/mL LC/MS/MS Validated
Dapsone Human Plasma 0.05 ng/mL LC/MS/MS Validated
Darunavir Human Plasma - LC/MS/MS Under Development
Deferasirox Human Plasma 0.1 µg/mL LC/MS/MS Validated
Deracoxib Dog Plasma 5.0 ng/mL LC/MS/MS Validated
Desvenlafaxine Human Plasma 2.0 ng/mL LC/MS/MS Validated
Dexamphetamine Human Plasma 0.5 ng/mL LC/MS/MS Validated
Dexlansoprazole Human Plasma 25.0 ng/mL LC/MS/MS Validated
Dexmethylphenidate Human Plasma 0.1000 ng/mL LC/MS/MS Validated
Dextromethorphan Human Plasma 0.1 ng/mL LC/MS/MS Validated
Diclofenac Human Plasma 0.04 ng/mL LC/MS/MS Validated
Diclofenac Human Plasma 5 ng/mL LC/MS/MS Validated
Diclofenac/Esomeprazole (combined single method) Human Plasma 5.0/2.5 ng/mL LC/MS/MS Validated
Dicyclomine (Dicycloverine) Human Plasma 1.0 ng/mL LC/MS/MS Validated
Didanosine Human Plasma 10.0 ng/mL LC/MS/MS Validated
Dienogest Human Plasma 0.5 ng/mL LC/MS/MS Validated
Diflunisal Human Plasma 1.0 µg/mL LC/MS/MS Validated
Digoxin Human Plasma 0.025 ng/mL LC/MS/MS Validated
Diltiazem, Desacetyl Diltiazem and N-Desmethyl Diltiazem Human Plasma 1.5 /0.3/0.3 ng/mL LC/MS/MS Validated
Diltiazem, Desacetyl Diltiazem and N-Desmethyl Diltiazem Human Plasma 0.6/0.12/0.21 ng/mL LC/MS/MS Validated
Dipyridamole Human Plasma 5.0 ng/mL LC/MS/MS Validated
Donepezil Human Plasma 0.1 ng/mL LC/MS/MS Validated
Donepezil and 6-O-Desmethyl Donepezil Human Plasma 0.1/0.02 ng/mL LC/MS/MS Validated
Doxazosin Human Plasma 0.1 ng/mL LC/MS/MS Validated
Doxepin and Nordoxepin Human Plasma 15.0/5.0 pg/mL LC/MS/MS Validated
Doxycycline Human Plasma 0.02 µg/mL LC/MS/MS Validated
Dronedarone and Desbutyl Dronedarone Human Plasma 0.5/0.5 ng/mL LC/MS/MS Validated
Drospirenone Human Plasma 0.5 ng/mL LC/MS/MS Validated
Droxidopa Human Plasma 5.5 ng/mL LC/MS/MS Validated
Duloxetine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Dutasteride Human Plasma 0.05 ng/mL LC/MS/MS Validated
Eletriptan Human Plasma 0.5 ng/mL LC/MS/MS Validated
Empagliflozin Human Plasma 1.0 ng/mL LC/MS/MS Validated
Emtricitabine Human Plasma 5.0 ng/mL LC/MS/MS Validated
Enalapril and Enalaprilat Human Plasma 0.5/0.5 ng/mL LC/MS/MS Validated
Enoxaparin Sodium Anti Factor IIa Human Plasma 0.030 IU/mL Chromogenic Validated
Enoxaparin Sodium Anti Factor Xa (Chromogenic assay) Human Plasma 0.050 IU/mL Chromogenic Validated
Enoxaparin sodium Anti Factor Xa (Clotting assay) Human Plasma 0.075 IU/mL Clot based Validated
Enrofloxacin Dog Plasma 10.0 ng/mL LC/MS/MS Validated
Enrofloxacin Cat Plasma 10.0 ng/mL LC/MS/MS Validated
Entecavir Human Plasma 0.04 ng/mL LC/MS/MS Validated
Enzalutamide Human Plasma 0.05 µg/mL LC/MS/MS Validated
Enzalutamide Human Plasma 0.10 µg/mL LC/MS/MS Validated
Eplerenone Human Plasma 0.010 µg/mL LC/MS/MS Validated
Erlotinib Human Plasma 5.0 ng/mL LC/MS/MS Validated
Erythromycin Human Plasma 10.0 ng/mL LC/MS/MS Validated
Erythropoietin Human Serum 3.5 mIU/mL ELISA Validated
Erythropoietin Immunogenicity assay Human Serum 248.48 ng/mL ELISA Validated
Escitalopram Human Plasma 0.2 ng/mL LC/MS/MS Validated
Esomeprazole Human Plasma 4.0 ng/mL LC/MS/MS Validated
Ethacrynic acid Human Plasma 2.0 ng/mL LC/MS/MS Validated
Ethinyl Estradiol Human Plasma 1.0 pg/mL LC/MS/MS Validated
Everolimus Human Plasma - LC/MS/MS Under Development
Exemestane Human Plasma 0.1 ng/mL LC/MS/MS Validated
Exemestane Human Plasma 0.2 ng/mL LC/MS/MS Validated
Ezetimibe + simvastatin Human Plasma - LC/MS/MS Under Development
Ezetimibe and Ezetimibe Glucuronide Human Plasma 0.025/0.25 ng/mL LC/MS/MS Validated
Famotidine Human Plasma 1.0 ng/mL LC/MS/MS Validated
Febuxostat Human Plasma 0.02 µg/mL LC/MS/MS Validated
Felbamate Human Plasma 0.4 µg/mL LC/MS/MS Validated
Fenofibric Acid Human Plasma 0.05 µg/mL LC/MS/MS Validated
Fentanyl Human Plasma 2.000 pg/mL LC/MS/MS Validated
Ferrous Human Plasma - LC/MS/MS Upcoming
Finasteride Human Plasma 0.1 ng/mL LC/MS/MS Validated
Flecainide Human Plasma 1.0 ng/mL LC/MS/MS Validated
Fluconazole Human Plasma 0.1 µg/mL LC/MS/MS Validated
Fluconazole Human Plasma 0.025 µg/mL LC/MS/MS Validated
Flunarizine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Fluoxetine Human Plasma 0.2000 ng/mL LC/MS/MS Validated
Fluoxetine and Norfluoxetine Human Plasma 0.5/0.5 ng/mL LC/MS/MS Validated
Flupirtine and Acetylated Flupirtine Human Plasma 8.0/2.0 ng/mL LC/MS/MS Validated
Follicle stimulating hormone (FSH) Human Serum 30.0 pg/mL ELISA Validated
Fosfomycin Human Plasma 0.5 ng/mL LC/MS/MS Upcoming
Fosinoprilat Human Plasma 5.0 ng/mL LC/MS/MS Validated
Furosemide Human Plasma 10.0 ng/mL LC/MS/MS Validated
Gabapentin Human Plasma 20.0 ng/mL LC/MS/MS Validated
GCSF Human Serum 250.0 pg/mL ELISA Developed
GCSF immunogenicity assay Human Serum - ELISA Under Development
Gestodene Human Plasma 0.05 ng/mL LC/MS/MS Validated
Gliclazide Human Plasma 0.01 µg/mL LC/MS/MS Validated
Glipizide Human Plasma 3.0 ng/mL LC/MS/MS Validated
Glucose Human Serum 25 mg/dL Chromogenic (GOD-POD) Under Development
Glyburide Human Plasma 1.0 ng/mL LC/MS/MS Validated
Granisetron Human Plasma 0.02 ng/mL LC/MS/MS Validated
Growth Hormone Human Serum 75.0 pg/mL ELISA Validated
Guaifenesin Human Plasma 20.0 ng/mL LC/MS/MS Validated
Guanfacine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Hemolytic potential of drug Human blood - Chromogenic Under Development
Hep test (LMWH by Anti-Xa) Human Plasma 0.075 IU/mL Clot based Validated
Her2 Human Serum 78.1 pg/mL ELISA Under Development
Hydrochlorothiazide Human Plasma 0.5 ng/mL LC/MS/MS Validated
Hydrocortisone Human Plasma 4.0 ng /mL LC/MS/MS Validated
Hydromorphone Human Plasma 0.05000 ng/mL LC/MS/MS Validated
Hydroxychloroquine Human Plasma - LC/MS/MS Upcoming
Hydroxyzine and Cetirizine Human Plasma 0.4/1.4 ng/mL LC/MS/MS Validated
Ibrutinib Human Plasma 0.4 ng/mL LC/MS/MS Validated
Ibrutinib Human Plasma 10.0 ng/mL LC/MS/MS Upcoming
Ibuprofen Human Plasma 0.05 µg/mL LC/MS/MS Validated
Ibuprofen Human Plasma 0.2 µg/mL LC/MS/MS Validated
Imatinib Human Plasma 10.0 ng/mL LC/MS/MS Validated
Imatinib Human Plasma - LC/MS/MS Upcoming
Imipramine and Desipramine Human Plasma 0.5/0.25 ng/mL LC/MS/MS Validated
Indapamide Human Blood 2.0 ng/mL LC/MS/MS Validated
Insulin Like Growth Factor-I (IGF-I) Human Serum 0.094 ng/mL ELISA Validated
Irbesartan Human Plasma 5.0 ng/mL LC/MS/MS Validated
"Isosorbide Dinitrate, Isosorbide-5-Mononitrate, Isosorbide-2-Mononitrate " Human Plasma 4.0/4.0/4.0 ng/mL LC/MS/MS Validated
Isosorbide Dinitrate,Isosorbide-2-Mononitrate, Isosorbide-5-Mononitrate Human Plasma 1.0/2.0/6.0 ng/mL LC/MS/MS Validated
Isosorbide Mononitrate Human Plasma 10.0 ng/mL LC/MS/MS Validated
Isotretinoin Human Plasma 0.6 ng/mL LC/MS/MS Upcoming
Itraconazole and Hydroxy Itraconazole Human Plasma 1.0/2.0 ng/mL LC/MS/MS Validated
Ivabradine and N-Desmethyl Ivabradine Human Plasma 1.0/0.1 ng/mL LC/MS/MS Validated
Lacosamide Human Plasma 0.01 µg/mL LC/MS/MS Validated
Lamivudine, Zidovudine and Abacavir Human Plasma 20.0/20.0/40.0 ng/mL LC/MS/MS Validated
Lamotrigine Human Plasma 10.0 ng/mL LC/MS/MS Validated
Lamotrigine Human Plasma 0.04 µg/mL LC/MS/MS Validated
Lansoprazole Human Plasma 2.0 ng/mL LC/MS/MS Validated
Ledipasvir Human Plasma 3.0 ng/mL LC/MS/MS Validated
Lenalidomide Human Plasma 2.0 ng/mL LC/MS/MS Validated
Levetiracetam Human Plasma 0.3 µg/mL LC/MS/MS Validated
Levodopa and Carbidopa Human Plasma 10.00/2.0 ng/mL LC/MS/MS Validated
Levodopa and Carbidopa Human Plasma 10.0/0.5 ng/mL LC/MS/MS Validated
Levodopa and Carbidopa Human Plasma 10.0/1.0 ng/mL LC/MS/MS Validated
Levofloxacin Human Plasma 0.05 µg/mL LC/MS/MS Validated
Levomefolate Human Plasma 3.0 ng/mL LC/MS/MS Validated
Levomilnacipran Human Plasma 1.0 ng/mL LC/MS/MS Validated
Levonorgestrel Human Plasma 0.1 ng/mL LC/MS/MS Validated
Levothyroxine Human Serum 35.0 ng/mL LC/MS/MS Validated
Levothyroxine Human Serum 3.5 μg/dL ELISA Validated
Levothyroxine (Total T4) Human Serum 3.5 µg/dL ELISA Validated
Lidocaine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Linagliptine Human Plasma 0.1 ng/mL LC/MS/MS Validated
Lio thyronine Human Serum 0.5 ng/mL ELISA Validated
Liothyronine (Total T3) Human Serum 0.5 ng/mL ELISA Validated
Lisinopril Human Plasma 1.0 ng/mL LC/MS/MS Validated
LMWH Anti Factor IIa Human Plasma 0.030 IU/mL Chromogenic Validated
LMWH Anti Factor Xa Human Plasma 0.050 IU/mL Chromogenic Validated
LMWH for APTT Human Plasma NA Clot based Validated
Loperamide Human Plasma - LC/MS/MS Under Development
Loratadine and Descarboethoxyloratadine Human Plasma 0.02/0.02 ng/mL LC/MS/MS Validated
Lorcaserin Human Plasma 0.5 ng/mL LC/MS/MS Validated
Lubiprostone Human Plasma - LC/MS/MS Upcoming
Lurasidone Human Plasma 0.2 ng/mL LC/MS/MS Validated
Macitentan Human Plasma 1.0 ng/mL LC/MS/MS Validated
Marbofloxacin Dog Plasma 5 ng/mL LC/MS/MS Validated
Marbofloxacin Cat Plasma 5 ng/mL LC/MS/MS Validated
Mebeverine Human Plasma - LC/MS/MS Upcoming
Medroxyprogesterone acetate Human Plasma 0.025 ng/mL LC/MS/MS Validated
Meloxicam Dog Plasma 5.0 ng/mL LC/MS/MS Validated
Meloxicam Human Plasma - LC/MS/MS Under Development
Memantine Human Plasma 0.1 ng/mL LC/MS/MS Validated
Mesalamine Human Plasma 4.0 ng/mL LC/MS/MS Validated
Mesalamine Human Plasma 2.0 ng/mL LC/MS/MS Validated
Metaxalone Human Plasma 25.0 ng/mL LC/MS/MS Validated
Metformin Human Plasma 10.0 ng/mL LC/MS/MS Validated
Methenamine Human Plasma 0.25 µg/mL LC/MS/MS Validated
Methotrexate Human Plasma 3.0 ng/mL LC/MS/MS Validated
Methylergonovine Human Plasma 0.5 ng/mL LC/MS/MS Validated
Methylphenidate Human Plasma 0.1 ng/mL LC/MS/MS Validated
Methylprednisolone Human Plasma 1.0 ng/mL LC/MS/MS Validated
Metoclopramide Human Plasma 0.25 ng/mL LC/MS/MS Validated
Metolazone Human Plasma 0.25 ng/mL LC/MS/MS Validated
Metoprolol Human Plasma 0.3 ng/mL LC/MS/MS Validated
Metronidazole Human Plasma 2.0 ng/mL LC/MS/MS Validated
Metronidazole Human Plasma 0.2 µg/mL LC/MS/MS Validated
Midodrine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Minocycline Human Plasma 20.0 ng/mL LC/MS/MS Validated
Mirabegron Human Plasma 0.2 ng/mL LC/MS/MS Validated
Mirtazapine Human Plasma 0.25 ng/mL LC/MS/MS Validated
Misoprostol Human Plasma 7.5 pg/mL LC/MS/MS Validated
Modafinil Human Plasma 0.05 µg/mL LC/MS/MS Validated
Monomethyl Fumarate Human Plasma 0.02 µg/mL LC/MS/MS Validated
Monteleukast Human Plasma 2.0 ng/mL LC/MS/MS Validated
Nadolol Human Plasma 1.0 ng/mL LC/MS/MS Validated
Naproxen Human Plasma 0.2 µg/mL LC/MS/MS Validated
Nateglinide Human Plasma 0.05 µg/mL LC/MS/MS Validated
Nevirapine Human Plasma 0.03 µg/mL LC/MS/MS Validated
Niacin and Nicotinuric Acid Human Plasma 5.0/2.5 ng/mL LC/MS/MS Validated
Nifedipine Human Plasma 0.5 ng/mL LC/MS/MS Validated
Nitisinone Human Plasma 10 ng/mL LC/MS/MS Upcoming
Nitrofurantoin Human Plasma 5.0 ng/mL LC/MS/MS Validated
Nitrofurantoin Human Plasma 1.0 ng/mL LC/MS/MS Validated
Norethindrone Human Plasma 0.1 ng/mL LC/MS/MS Validated
Norethindrone Human Plasma 0.2 ng/mL LC/MS/MS Validated
Norgestimate and 17-Desacetyl norgestimate Human Plasma 2.0/36.0 pg/mL LC/MS/MS Validated
Nortriptyline and 10-Hydroxy Nortriptyline Human Plasma 0.2/0.4 ng/mL LC/MS/MS Validated
Olmesartan Human Plasma 10.0 ng/mL LC/MS/MS Validated
Olopatadine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Omeprazole Human Plasma 2.0 ng/mL LC/MS/MS Validated
Omeprazole Human Plasma 5.0 ng/mL LC/MS/MS Validated
Oseltamivir and Oseltamivir Carboxylic Acid Human Plasma 0.5/5.0 ng/mL LC/MS/MS Validated
Ospemifene Human Serum 3.0 ng/mL LC/MS/MS Validated
"Oxcarbazepine and 10,11-dihydro-10-hydroxy-carbamazepine" Whole Blood 0.02/0.07 µg/mL LC/MS/MS Validated
Oxybutynin and Desethyl oxybutynin Human Plasma 0.05/0.2 ng/mL LC/MS/MS Validated
Oxybutynin and N-Desethyl Oxybutynin Human Plasma 0.15/0.3 ng/mL LC/MS/MS Validated
Oxycodone Human Plasma 0.2 ng/mL LC/MS/MS Upcoming
Oxymorphone Human Plasma - LC/MS/MS Under Development
Paliperidone Human Plasma 0.2 ng/mL LC/MS/MS Validated
Pantoprazole Human Plasma 2.0 ng/mL LC/MS/MS Validated
Parampanel Human Plasma 1.0 ng/mL LC/MS/MS Validated
Paroxetine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Peg-GCSF Human Serum 250.0 pg/mL ELISA Under Development
Perindopril / Perindoprilat Human Plasma 0.5/0.2 ng/mL LC/MS/MS Validated
Perindopril and Perindoprilat Human Plasma 0.5/0.2 ng/mL LC/MS/MS Validated
Perphenazine Human Plasma 0.015 ng/mL LC/MS/MS Validated
Phenazopyridine Human Plasma 0.2 ng/mL LC/MS/MS Validated
Phentermine and Topiramate Human Plasma - LC/MS/MS Under Development
Pimobendan Human Plasma - LC/MS/MS Under Development
Pindolol Human Plasma 1.0 ng/mL LC/MS/MS Validated
Pindolol Human Plasma - LC/MS/MS Upcoming
Pioglitazone, Hydroxy pioglitazone and Keto pioglitazone Human Plasma 5.0/2.5/2.5 ng/mL LC/MS/MS Validated
Pitavastatin Human Plasma 0.2 ng/mL LC/MS/MS Validated
Pomalidomide Human Plasma 0.2 ng/mL LC/MS/MS Validated
Pomalidomide Human Plasma - LC/MS/MS Upcoming
Potassium Human Urine 100.0 µg/mL ICP-OES Validated
Pramipexole Human Plasma 25.0 pg/mL LC/MS/MS Validated
Prasugrel active metabolite (R138727) Human Plasma 0.2 ng/mL LC/MS/MS Validated
Prasugrel inactive metabolite (R95913) Human Plasma 0.25 ng/mL LC/MS/MS Validated
Prazosin Human Plasma 0.2 ng/mL LC/MS/MS Validated
Prednisone and prednisolone Human Plasma 0.2/2.0 ng/mL LC/MS/MS Validated
Pregabalin Human Plasma 0.05 µg/mL LC/MS/MS Validated
Progesterone Human Plasma 0.5 ng/mL LC/MS/MS Validated
Progesterone Human Plasma 0.05 ng/mL LC/MS/MS Validated
Promethazine Human Plasma 0.5 ng/mL LC/MS/MS Validated
Propafenone and 5-Hydroxy Propafenone Human Plasma 0.2/0.1 ng/mL LC/MS/MS Validated
Propafenone and 5-Hydroxy Propafenone Human Plasma 0.075/0.15 ng/mL LC/MS/MS Validated
Propranolol and 4-Hydroxy Propranolol (Total) Human Plasma 0.9955/0.7875 ng/mL LC/MS/MS Validated
Pyridostigmine Human Plasma 0.75 ng/mL LC/MS/MS Validated
Quetiapine Human Plasma 1.0 ng/mL LC/MS/MS Validated
Rabeprazole Human Plasma 2.0 ng/mL LC/MS/MS Validated
"Raloxifene, Raloxifene 4 glucuronide and Raloxifene 6 glucuronide" Human Plasma 0.01/4.0/0.8 ng/mL LC/MS/MS Validated
Ramipril and Ramiprilat Human Plasma 0.1/0.1 ng/mL LC/MS/MS Validated
Ranitidine Human Plasma 10 ng/mL LC/MS/MS Validated
Ranolazine Human Plasma 5.0 ng/mL LC/MS/MS Validated
Rasagiline Human Plasma - LC/MS/MS Upcoming
Repaglinide Human Plasma 0.2 ng/mL LC/MS/MS Validated
Ribavirin Human Plasma 20.0 ng/mL LC/MS/MS Validated
Rifabutin Human Plasma 2 ng/mL LC/MS/MS Validated
Rituximab Human Serum 1.5 μg/mL ELISA Under Development
Rituximab immunogenicity assay Human Serum - ELISA Under Development
Rivastigmine Human Plasma 50.0 pg/mL LC/MS/MS Validated
Rivastigmine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Rizatriptan Human Plasma 0.2 ng/mL LC/MS/MS Validated
Rosuvastatin and N-Desmethyl Rosuvastatin Human Plasma 0.1/0.4 ng/mL LC/MS/MS Validated
S-(+)-Manidipine and R-(-)-Manidipine Human Plasma 0.05 (R)/0.05(S) ng/mL LC/MS/MS Validated
Sacubritil Human Plasma - LC/MS/MS Under Development
Salsalate Human Plasma 0.125 µg/mL LC/MS/MS Validated
Saroglitazar Human Plasma 0.2 ng/mL LC/MS/MS Validated
Saroglitazar Sulfoxide Human Plasma 0.1 ng/mL LC/MS/MS Validated
Scopolamine Human Plasma - LC/MS/MS Under Development
Sertraline and N-Desmethylsertraline Human Plasma 0.5/0.5 ng/mL LC/MS/MS Validated
Silodosin and Silodosin Glucuronide Human Plasma 0.2/0.3 ng/mL LC/MS/MS Validated
Silodosin and Silodosin Glucuronide Human Plasma - LC/MS/MS Under Development
Sirolimus Human Plasma - LC/MS/MS Under Development
Sitagliptin Human Plasma 2.0 ng/mL LC/MS/MS Validated
Sofosbuvir and Sofosbuvir metabolite GS331007 Human Plasma 5.0/5.0 ng/mL LC/MS/MS Validated
Solifenacin Human Plasma 0.1 ng/mL LC/MS/MS Validated
Spironolactone Human Plasma 0.5 ng/mL LC/MS/MS Validated
Tacrolimus Whole Blood 0.2 ng/mL LC/MS/MS Validated
Tadalafil Human Plasma 2.0 ng/mL LC/MS/MS Validated
Tamoxifen Human Plasma 0.5 ng/mL LC/MS/MS Validated
Tamsulosin Human Plasma 0.2 ng/mL LC/MS/MS Validated
Telmisartan Human Plasma 0.5 ng/mL LC/MS/MS Validated
Teneligliptin Human Plasma 1.000 ng/mL LC/MS/MS Validated
Tenofovir Human Plasma - LC/MS/MS Under Development
Teriflunamide Human Plasma 0.02 µg/mL LC/MS/MS Validated
Teriparatide Human Plasma 20.0 pg/mL ELISA Developed
Testosterone Human Serum 0.05000 ng/mL LC/MS/MS Validated
Tetrabenazine and Hydroxy Tetrabenazine Human Plasma 0.005/0.5 ng/mL LC/MS/MS Validated
Tissue factor pathway inhibitor (TFPI) Human Plasma 31.25 ng/mL ELISA Validated
Tizanidine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Tizanidine Human Plasma 0.1 ng/mL LC/MS/MS Validated
Tofacitinib Human Plasma 0.5 ng/mL LC/MS/MS Validated
Tofacitinib Human Plasma - LC/MS/MS Upcoming
Tolterodine and 5-Hydroxy methyl tolterodine Human Plasma 0.02/0.02 ng/mL LC/MS/MS Validated
Tolvaptan Human Plasma 0.5 ng/mL LC/MS/MS Validated
Topiramate Human Plasma 2.0 ng/mL LC/MS/MS Validated
Topiramate Human Plasma 50.0 ng/mL LC/MS/MS Validated
Torsemide Human Plasma - LC/MS/MS Under Development
Tramadol Human Plasma - LC/MS/MS Upcoming
Tramadol and O-Desmethyltramadol Human Plasma 1.0/0.5 ng/mL LC/MS/MS Validated
Trandolapril and Trandolaprilat Human Plasma 0.05/0.1 ng/mL LC/MS/MS Validated
Trastuzumab Human Serum 1.0 ug/mL ELISA Under Development
Trastuzumab immunogenicity assay Human Serum - ELISA Under Development
Trazodone and M-CPP Human Plasma 10.0/0.5 ng/mL LC/MS/MS Validated
Triamcinolone Human Plasma - LC/MS/MS Under Development
Triamterene Human Plasma 3.0 ng/mL LC/MS/MS Validated
Triamterene and Hydrochlorothiazide Human Plasma 2.0/0.5 ng/mL LC/MS/MS Validated
Triazolam Human Plasma 0.1 ng/mL LC/MS/MS Validated
Trientine Human Plasma - LC/MS/MS Under Development
Trimetazidine Human Plasma 0.5 ng/mL LC/MS/MS Validated
Trospium Human Plasma 0.04 ng/mL LC/MS/MS Validated
Ulipristal acetate Human Plasma 0.1 ng/mL LC/MS/MS Upcoming
Ursodiol, Glycoursodeoxycholic acid (GUDCA) and Tauroursodeoxycholic acid (TUDCA) Human Plasma 0.07/0.07/0.007 µg/mL LC/MS/MS Validated
Valacylovir and Acyclovir Human Plasma 3.0/40.0 ng/mL LC/MS/MS Validated
Valproic acid Human Plasma 0.5 µg/mL LC/MS/MS Validated
Valsartan Human Plasma 0.01 µg/mL LC/MS/MS Validated
Vancomycin Human Plasma 0.5 µg/mL LC/MS/MS Validated
Vardenafil Human Plasma 0.125 ng/mL LC/MS/MS Validated
Venlafaxine and O-Desmethylvenlafaxine Human Plasma 2.0/2.0 ng/mL LC/MS/MS Validated
Verapamil and Norverapamil Human Plasma 1.0/1.0 ng/mL LC/MS/MS Validated
Vilazodone Human Plasma 0.1 ng/mL LC/MS/MS Validated
Vildagliptin Human Plasma 2.0 ng/mL LC/MS/MS Validated
Voriconazole Human Plasma 10.0 ng/mL LC/MS/MS Validated
Vortioxetine Human Plasma 0.05 ng/mL LC/MS/MS Validated
Warfarin Human Plasma 10.0 ng/mL LC/MS/MS Validated
Zafirlukast Human Plasma 5.0 ng/mL LC/MS/MS Validated
Zidovudine and Lamivudine Human Plasma 6.0/6.0 ng/mL LC/MS/MS Validated
Zileuton Human Plasma 0.03 µg/mL LC/MS/MS Validated
Ziprasidone Human Plasma 0.5 ng/mL LC/MS/MS Validated
Zolmitriptan and N-Desmethyl zolmitriptan Human Plasma 0.1/0.075 ng/mL LC/MS/MS Validated
Zolpidem Human Plasma 1.0 ng/mL LC/MS/MS Validated

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