PRODUCTS THERAPEUTIC CATEGORY AVAILABLE STATUS ON
Tech pack GMP EUWC US DMF EDMF/
CEP
MEXICO/
BRAZIL DMF
TDMF KDMF/
JDMF
PATENT
Anagrelide HCl Antithrombocythemic A WHO A -
Azithromycin Dihydrate Macrolides A WHO A -
Agomelatine Form II Antidepressant A WHO A A INDIA 851/MUM/2014
Aprepitant Form I And Form II

(CEP 2019-093)

Anti-Emetic A WHO A A India 20116210 09118
Bisoprolol Hemifumarate 

(CEP NO..2013-342)

Anti Hypertensive A WHO A A A -
Bazedoxifene Acetate Form A & B Selective Estrogen Receptor Modulator A INDIA 2020 -
Chloramphenicol Base & Palmitate Anti-Bacterial A WHO A -
Cinacalcet Hcl Form I Calcimimetic A WHO A A PCT/India
IB2015 056205
Dipyridamol Antiplatele A INDIA 2019
Erythromycin Base -

CEP NO RO-CEP 2009-267

MACROLIDES A WHO A A A
Erythromycin Ethyl Succinate

CEP-2017-281

A WHO A U/P
Erythromycin Stearate A WHO A
Esmolol Hcl Cardiology A WHO A
Fluvoxamine Maleate Antidepressant A WHO A
Linagliptin Form A Anti-diabetic A INDIA 2020
Mirabegron Form α Beta-3 adrenergic A INDIA 2020 India 20162100 9117
Rivaroxaban Form I Anticoagulant A WHO A India PCT/IB20 16/053346
Treprostinil Monohydrate Vasodilator A WHO A

REMARKS - A : AVAILABLE ✔ - DOCUMENTS READY FOR FILING




Under Development


PRODUCTS THERAPEUTIC CATEGORY DEVELOPMENT TIME LINE
Dabigatran Etexilate Mesylate Anticoagulant 2019/2020
Dapagliflozin Propanediol Monohydrate Antidiabetic 2018/2019
Empagliflozin Antidiabetic 2019/2020
Edoxaban Tosylate Monohydrate Anticoagulant 2019/2020



Under Evaluation


PRODUCTS THERAPEUTIC CATEGORY
Apixaban Anticoagulant
Luliconazole Antifungal
Pazopanib HCl Oncology
Pomalidomide Immunomodulatory agent
Pirfenidone Idiopathic Pulmonary Fibrosis
Sapropterin Di HCl Phenylalanine Hydroxylase activator
Sorafenib Tosylate Oncology
Tamsulocin HCl Alpha-1a adrenergic antagonist
Teriflunomide Immunomodulatory agent
Tofacitinib Citrate Rheumatoid arthritis


The above products are offered as per BP/EP/USP/JP and FP and as per customers in-house Specifications.

Also available in Microfine
*Indian GMP- as per schedule M
*WHO GMP-Issued by Indian FDA to the format recommended by WHO
* EU-WC- EU Written confirmation


The above products are intended to supplied solely as per usage reasonably relating to the testing and development of
information, regulatory submission, strictly according to the section 107A of the Indian Patent Act, 1970



DISCLAIMER

Mehta API has technical capabilities of manufacturing Linagliptin and Rivaroxaban and their Intermediates. However, these products will be offered only to the markets where product and process are not infringing. The quantities for the purpose of Research and Development of product for regulatory submission will be offered only to countries where such exemptions exists (Hatch Waxman Act/Bolar exemption) during the validity of the patent. While MAPL offers to work with the clients on status verification of patent, the ultimate responsibility vests with the buyer. Recipients of these APIs and intermediates are requested to make their independent evaluation and determination as to the patent status prior to the use of material and information in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purpose.

  • REFERENCE STANDARDS OF API & IMPURITIES AVAILABLE


Email: info@mehtaapi.com I Website: www.mehtaapi.com