Addition of Clinical-Scale Sachet and Blister Packaging Services Further Broadens CTS Offerings; Successful Audit of Facility by EU Qualified Person (QP) Represents Key Step for Attracting and Onboarding European CTS Customers
GAINESVILLE, Ga., June 02, 2021 (GLOBE NEWSWIRE) — Recro Pharma, Inc. (“Recro”; NASDAQ: REPH), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today announced that it has expanded the clinical capabilities of the company’s growing Clinical Trial Services (CTS) offerings. Included among the newly added CTS capabilities are clinical-scale sachet and blister packaging for clinical trial pharmaceuticals.
Additionally, Recro has established a relationship with a European Union Qualified Person (QP) for its CTS offerings following a successful review process. This QP has audited the company’s facility and stated that Recro meets the relevant GMP manufacturing standards and requirements for clinical trial materials to be used in the EU. Based on this audit, the QP organization has agreed that it can represent Recro’s clients for release of materials in the EU. A QP declaration is required for any biotechnology or pharmaceutical company seeking to conduct a clinical trial in Europe using a drug product manufactured in a non-EU country, allowing Recro to support the Europe-based clinical trial efforts of its customers.
“While our addition of CTS offerings is not yet a year old, it has already provided opportunities for our existing clients to expand their scope of work with Recro, as well as serving as a gateway for attracting new customers. This is highlighted by the fact that our recent expansion of packaging services has played an important role in increased client interest and attracting new business,” stated Scott Rizzo, senior vice president and general manager of Recro. “In addition to the growing traction of the CTS offerings in the U.S., we are now positioned to carry momentum into the European market based on the successful QP audit. Taken together, these expanded capabilities will allow us to continue the positive trajectory for our CTS offerings, which typically have the benefit of a shorter sales and earnings cycle, as they become a more meaningful contributor to the overall growth of Recro.”
Recro (NASDAQ: REPH) is a contract development and manufacturing organization (CDMO) with capabilities from early feasibility to commercial manufacturing. With an expertise in solving complex manufacturing problems, Recro is a CDMO providing oral solid dosage form development, end-to-end regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified release oral solid dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 120,000 square feet, in Gainesville, Georgia.
For more information about Recro’s CDMO solutions, visit recrocdmo.com.
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, the Company’s expectations regarding the completion of the proposed public offering, the Company’s use of proceeds from the proposed offering, and other statements. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or inventory rebalancing or disruption in raw materials or supply chain; demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
Contacts: Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 email@example.com Tim Brons (Media) Vida Strategic Partners 415-675-7402 firstname.lastname@example.org Ryan D. Lake (CFO) Recro (484) 395-2436 ryan.lake@recroCDMO.com