SACRAMENTO, Calif., March 3, 2022 (GLOBE NEWSWIRE) — Alto Ingredients, Inc. (NASDAQ: ALTO)a leading producer and marketer of specialty alcohols and essential ingredients, announced that its plant in Beijing, Illinois is now ICH Q7 and EXCiPACT Good Manufacturing Practices (GMP) certified.
The internationally recognized ICH Q7 states that Alto Ingredients’ specialty alcohol is certified for use as an active pharmaceutical ingredient.
EXCiPACT GMP, also a globally recognized standard, certifies the use of excipients in the pharmaceutical industry; excipients are the inactive components of a drug or drug, such as solvents, carriers, or tinctures.
Mike Kandris, CEO of Alto Ingredients, said, “We are proud to have achieved two certifications in February 2022 for our Alto Beijing facility, complementing the same two certifications we achieved at Alto ICP in February 2021 and creating redundancy across the Beijing campus. Demonstrating our commitment to providing our customers with high quality, reliability and security of supply, these certifications are sought-after and valuable differentiators in the marketplace. They facilitate the reporting and maintenance of all quality aspects required for regulatory purposes for our customers, saving resources, time and money, and when in place, position Alto as a preferred supplier. In addition, these distinctions open the doors to new quality customers and markets. »
Regulators require excipient users to qualify their suppliers based on GMP/GDP audits. Regulators have indicated that third-party supplier auditing is acceptable if a reputable certification body issues certificates and audit reports employing qualified auditors whose credibility can be demonstrated in the appropriate GMP/GMP standards and in the needs of the pharmaceutical industry. EXCiPACT is a not-for-profit organization that owns and manages the oversight of such an independent, high-quality certification program available to manufacturers and distributors of pharmaceutical excipients worldwide. For more information, please visit https://www.excipact.org.
About ICH Q7
The International Council for Harmonization (ICH) guideline aims to provide guidance on Good Manufacturing Practices (GMP) for the manufacture of Active Pharmaceutical Ingredients (APIs) under an appropriate quality management system . It is also intended to help ensure that APIs meet the quality and purity requirements that they claim or are expected to possess. This guideline applies to the manufacture of APIs intended for use in (medicinal) drugs for human use. It applies to the manufacture of sterile APIs only up to the point immediately before the APIs are rendered sterile. Sterilization and aseptic processing of sterile APIs is not covered by this guide, but should be done in accordance with GMP guidelines for pharmaceutical (medicinal) products as defined by local authorities. For more information, please see: https://www.ich.org/page/quality-guidelines.
About Alto Ingredients, Inc.
Alto Ingredients, Inc. (ALTO) is a leading producer and marketer of specialty alcohols and essential ingredients. The company focuses on products for four key markets: health, home and beauty; Food and drinks; 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 in this communication that refer to or include the estimated or expected future results of Alto Ingredients or other expressions of non-historical facts are forward-looking statements that reflect Alto Ingredients’ current perspective on trends and existing information at the date of the communication. Forward-looking statements will generally be accompanied by words such as “anticipate”, “believe”, “plan”, “could”, “should”, “estimate”, “expect”, “expect”, “outlook”, ” direction,” “intend,” “may,” “could,” “will,” “possible,” “potential,” “predict,” “project,” or other similar words, phrases or expressions. These forward-looking statements include, but are not limited to, statements regarding the benefits of ICH Q7 and EXCiPACT Good Manufacturing Practices (GMP) certifications at Alto Ingredients’ facility in Beijing, Illinois; and other plans, objectives, expectations and intentions of Alto Ingredients. It is important to note that Alto Ingredients plans, goals, expectations and intentions are not predictions of actual performance. Actual results may differ materially from Alto Ingredients’ current expectations depending on a number of factors affecting Alto Ingredients’ business. These factors include, among others, Alto Ingredients’ ability to maintain and operate its ICH Q7 and EXCiPACT GMP certifications; unfavorable 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 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 expected size of markets and continued demand for Alto Ingredients’ products; the impact of competitive products and prices; the risks and uncertainties inherent in the specialty alcohol production and marketing industries; changes in generally accepted accounting principles; compliance with government regulations applicable to Alto Ingredients’ facilities, products and/or activities; changes in laws, regulations and governmental policies; loss of senior management or key personnel; and other events, factors and risks previously and from time to time disclosed in Alto Ingredients’ filings with the Securities and Exchange Commission, including, in particular, the 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 protected]
Company IR Contact:
Michael Kramer, Alto Ingredients, Inc., 916-403-2755, [email protected]
IR agency contact:
Kirsten Chapman, LHA Investor Relations, 415-433-3777, [email protected]