Alto Ingredients Awarded Active Pharmaceutical Ingredient Certification
04 February 2021 - 12:30AM
Alto Ingredients, Inc. (NASDAQ: ALTO), a leading
producer of specialty alcohols and essential ingredients, announced
its Illinois Corn Processing (ICP) facility is now ICH Q7
certified.
Mike Kandris, Alto Ingredients’ CEO, said, “Our commitment to
provide our customers the absolute best quality products is
reflected by this significant achievement. In October of 2020, we
obtained our ISO 9001 certification, the world's most widely
recognized standard for quality management systems. Now with our
internationally recognized ICH Q7 certification, our alcohol is
certified for use as an active pharmaceutical ingredient. Markets
for our alcohol include use in beauty and oral care products such
as foundation and mouthwash, in addition to other uses within the
pharmaceutical and personal care product industries. Our dedication
to quality required to attain ICH Q7 allows us to safely and
consistently serve our domestic markets as well as a growing export
market.
“We thank our customers for assisting us in developing our
quality program and providing support through the successful
completion of our ICH Q7 audits. Attaining this certification
deepens our existing customer relationships and also opens the door
to new opportunities. With our ICP facility now ISO 9001 and ICH Q7
certified, we can more effectively meet anticipated customer demand
for our specialty alcohols and essential ingredients.”
About ICH Q7
The International Council for Harmonization (ICH) Guideline is
intended to provide guidance regarding Good Manufacturing Practice
(GMP) for the manufacturing of Active Pharmaceutical Ingredients
(APIs) under an appropriate system for managing quality. It is also
intended to help ensure that APIs meet the requirements for quality
and purity that they purport or are represented to possess.
This Guideline applies to the manufacture of APIs for use in
human drug (medicinal) products. It applies to the manufacture of
sterile APIs only up to the point immediately prior to the APIs
being rendered sterile. The sterilization and aseptic processing of
sterile APIs are not covered by this guidance but should be
performed in accordance with GMP guidelines for drug (medicinal)
products as defined by local authorities. For more information
please visit: https://www.ich.org/page/quality-guidelines.
About Alto Ingredients, Inc.
Alto Ingredients, Inc. (ALTO), formerly known as Pacific
Ethanol, Inc., is a leading producer of specialty alcohols and
essential ingredients. The company is focused on products for four
key markets: Health, Home & Beauty; Food & Beverage;
Essential Ingredients; and Renewable Fuels. The company’s customers
include major food and beverage companies and consumer products
companies. For more information please visit
www.altoingredients.com.
Safe Harbor Statement under the Private Securities
Litigation Reform Act of 1995
Statements and information contained in this communication that
refer to or include Alto Ingredients’ estimated or anticipated
future results or other non-historical expressions of fact are
forward-looking statements that reflect Alto Ingredients’ current
perspective of existing trends and information as of the date of
the communication. Forward looking statements generally will be
accompanied by words such as “anticipate,” “believe,” “plan,”
“could,” “should,” “estimate,” “expect,” “forecast,” “outlook,”
“guidance,” “intend,” “may,” “might,” “will,” “possible,”
“potential,” “predict,” “project,” or other similar words, phrases
or expressions. Such forward-looking statements include, but are
not limited to, statements concerning Alto Ingredients’ plans,
objectives, expectations and intentions. It is important to note
that Alto Ingredients’ objectives, expectations and intentions are
not predictions of actual performance. Actual results may differ
materially from Alto Ingredients’ current expectations depending
upon a number of factors affecting Alto Ingredients’ business.
These factors include, among others, adverse economic and market
conditions, including for specialty alcohols and essential
ingredients; export conditions and international demand for the
company’s products; fluctuations in the price of and demand for oil
and gasoline; raw material costs, including production input costs,
such as corn and natural gas; the effects – both positive and
negative – of COVID-19; and Alto Ingredients’ ability to maintain
and benefit from quality management certifications. These factors
also include, among others, the inherent uncertainty associated
with financial and other projections; the anticipated size of the
markets and continued demand for Alto Ingredients’ products; the
impact of competitive products and pricing; the risks and
uncertainties normally incident to the specialty alcohol production
and marketing industries; changes in generally accepted accounting
principles; successful compliance with governmental regulations
applicable to Alto Ingredients’ distilleries, products and/or
businesses; changes in laws, regulations and governmental policies;
the loss of key senior management or staff; and other events,
factors and risks previously and from time to time disclosed in
Alto Ingredients’ filings with the Securities and Exchange
Commission including, specifically, those factors set forth in the
“Risk Factors” section contained in Alto Ingredients’ Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on November 16, 2020.
Media Contact:
Bryon McGregor, Alto Ingredients, Inc., 916-403-2768,
mediarelations@altoingredients.com
Company IR Contact:
Michael Kramer, Alto Ingredients, Inc., 916-403-2755,
Investorrelations@altoingredients.com
IR Agency Contact:
Moriah Shilton, LHA Investor Relations, 415-433-3777,
Investorrelations@altoingredients.com
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