API Development and Manufacturing

Focusing on development and production of low volume, high value specialty Active Pharmaceutical Ingredients.

We develop novel patented processes, find “by-passes” to existing patents, develop new polymorphs, prepare DMFs and manufacture complex APIs.

Established in 1990 by Dr. Arie Gutman, FineTech has a proven track record of successfully developing and manufacturing low volume, high value complex APIs.  Our International team of highly qualified scientists and engineers work in our state-of-the-art FDA approved facility to meet our customers’ needs.

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  • Products

    We Offer fully developed commercial APIs

    All pilot and commercial API manufacturing is carried out in GMP-compliant and FDA-approved multipurpose reactors.

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  • Services

    We offer a wide variety of development, analytical and regulatory support services

    Spaning from paper chemistry and literature searches through pilot scale-up and commercialization.

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Company News

Oct. 2023
DMF for Eribuline mesylate was filed with the US FDA
Feb. 2023
GMP certificate was renewed following a successful inspection by the Israeli Ministry of Health
Jul. 2022
DMF for Eribuline mesylate was filed in 15 European Countries
Oct. 2015
GMP certificate was renewed following a successful inspection by the Israeli Ministry of Health
Dec. 2011
The Company was acquired by Opko Health, Inc
Jan. 2011
DMF for Latanoprost API was filed with Slovenia and Croatia Regulatory Authorities
Nov. 2010
DMF for Latanoprost API was filed with German and French Regulatory Authorities
Jul. 2010
DMF for Nabilone API was filed with Health Canada
Jun. 2010
The Company celebrated the 20th anniversary since its establishment
May. 2010
GMP certificate was renewed following a successful 4 day inspection of the Company’s facility and operations by the Israeli Ministry of Health
Apr. 2010
As part of a corporate restructuring, the Company was separated from RxElite and Dr. Arie L. Gutman became Chairman of the Board