SACRAMENTO, Calif., March 03, 2022 (GLOBE NEWSWIRE) -- 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.”
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.
Bryon McGregor, Alto Ingredients, Inc., 916-403-2768, email@example.com
Company IR Contact:
Michael Kramer, Alto Ingredients, Inc., 916-403-2755, firstname.lastname@example.org
IR Agency Contact:
Kirsten Chapman, LHA Investor Relations, 415-433-3777, email@example.com