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

Regulatory Inspections

Last Inspection in Nov 2015
Inspected facility in Nov 2006
Inspected facility in Jan 2009
Last inspection in Apr-May 2016
Inspected facility in Feb - Mar 2013
Last inspection in March 2013
Inspected facility in July 2013
Last inspected by Ministry of Health of Turkey in April 2013
Last inspection in Apr-May 2016