Alto Ingredients, Inc. Receives Additional Medical and Pharmaceutical Ingredient Certifications at Pekin, Illinois Campus
04 March 2022 - 12:30AM
Alto Ingredients, Inc. (NASDAQ: ALTO), a leading
producer and distributor of specialty alcohols and essential
ingredients, announced its Pekin, Illinois facility is now ICH Q7
and EXCiPACT Good Manufacturing Practices (GMP) certified.
- ICH Q7, internationally recognized,
states that the Alto Ingredients’ specialty alcohol is certified
for use as an active pharmaceutical ingredient.
- EXCiPACT GMP, also a globally
recognized standard, certifies for the use of excipients in the
pharmaceutical industry; excipients are the inactive components of
a drug or medication, such as solvents, carriers or tinctures.
Mike Kandris, Alto Ingredients’ CEO, said, “We are proud to have
earned two certifications in February 2022 for our Alto Pekin
facility, augmenting the same two certifications we secured at Alto
ICP in February of 2021 and creating redundancy throughout the
Pekin campus. Demonstrating our commitment to provide our customers
with high quality, reliability, and surety of supply, these
certifications are sought-after and valuable market
differentiators. They facilitate reporting and maintenance of all
the quality aspects required for regulatory purposes for our
customers, saving resources, time and money, and when in place,
position Alto as a preferred provider. Additionally, these
distinctions open doors to new high-quality customers and
markets.”
About EXCiPACT
Regulators require excipient users to qualify their suppliers
based on GMP/GDP audits. Regulators have indicated that third-party
auditing of suppliers is acceptable if a creditable certification
body issues certificates and audit reports by employing qualified
auditors who are demonstrably credible in suitable GMP/GDP
standards and in the needs of the pharmaceutical industry. EXCiPACT
is a non-profit organization that owns and manages oversight of
such an independent, high quality, third-party certification
program available to pharmaceutical excipient manufacturers and
distributors worldwide. For more information please visit
https://www.excipact.org.
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) is a leading producer and
distributor 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 the benefits of the ICH Q7
and EXCiPACT Good Manufacturing Practices (GMP) certifications at
Alto Ingredients’ Pekin, Illinois facility; and Alto Ingredients’
other plans, objectives, expectations and intentions. It is
important to note that Alto Ingredients’ plans, 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, Alto Ingredients’ ability to maintain and
exploit its ICH Q7 and EXCiPACT GMP certifications; 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; and the
effects – both positive and negative – of the coronavirus pandemic
and its resurgence or abatement. 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’ facilities, 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 12,
2021.
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:
Kirsten Chapman, LHA Investor Relations, 415-433-3777,
investorrelations@altoingredients.com
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