Boca Raton, FL and Coimbra, Portugal – Florida Pharmaceutical Products, LLC., also known as ‘FPP’ (www.flpharmaproducts.com) and ONConcept® (www.onconceptpharma.com), two pharmaceutical companies involved in development, sales, marketing and distribution of generic pharmaceuticals are pleased to announce the Approval of Abiraterone 500mg Tabs, ANDA generic for Zytiga® (Janssen), from the U.S. Food and Drug Administration (FDA).
ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with • metastatic castration-resistant prostate cancer (CRPC) • metastatic high-risk castration-sensitive prostate cancer (CSPC). Zytiga® peak sales exceeded $600 million. Current generic sales exceed $175 million according to IQVIA™ with limited competition.
This ANDA approval is the first this year for FPP, which expects at least 4 Approvals / Launches in 2023.
The collaboration includes ANDA development by ONConcept®, a strategic collaboration in the field of oncology between three independent and certified European pharmaceutical companies – Bluepharma, Helm and Welding.
ONConcept® developed the product and will manage the supply chain, which comprises a new, state-of-the-art, flexible, sustainable, specialized highly potent oral solid production plant in Portugal, Europe, while FPP will manage product sales, marketing and distribution within the United States. The product is available for immediate launch.
“We are excited about this opportunity for partnership with ONConcept® and to improve the lives of patients who will benefit from these therapies”, states Gina Campbell, SVP Commercial Operations for FPP.
Sergio Simoes, VP at Bluepharma, adds “This ANDA approval reinforces ONConcept® strategy to further growth in the US territory, particularly with reliable partners such as FPP”.
About Florida Pharmaceutical Products, LLC
Florida Pharmaceutical Products, LLC. (FPP) is a Boca Raton, Florida based pharmaceutical company involved in the development of Generic Pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US.
FPP brings affordably priced prescription medications from development to distribution for the benefit of patients.
About ONConcept®
ONConcept® project is a reliable, flexible, and high-quality European partnership able to serve global markets with differentiated, high-value medicines.
Portugal-based Bluepharma operates as a CDMO with all the capabilities needed to offer an integrated approach from development to commercial manufacturing. Together with the German partners Helm and Welding, the collaboration bundles its scientific and regulatory knowledge, enlarges the API sourcing network, offers its own intellectual property service, strengthens the individual market knowledge and access to realize a strong highly potent products’ portfolio. Currently the ONConcept® project had built a basket of more than 20 products.
For further information contact:
Florida Pharmaceutical Products, LLC, [email protected] or Bluepharma Indústria Farmacêutica, S.A. at [email protected].
Boca Raton, FL / Taiwan City, Taiwan (September 30, 2020) – Florida Pharmaceutical Products, LLC. (FPP) a pharmaceutical company involved in the Development, Sales, Marketing and Distribution of Generic Pharmaceuticals and Standard Chem. & Pharm. Co., Ltd (Standard) a company involved in the Development Manufacturing Distribution and Licensing of pharmaceuticals are pleased to announce the signing of an agreement for the Licensing, Supply and Distribution of an approved ANDA for Riluzole Tablets developed by Standard and approved by the FDA and scheduled to launch in November. The product has sales of approximately $5 million according to IQVIA™. The ANDA product will be sold and Distributed by FPP in the Quinn Label within the US. “We are pleased to be working with Standard on this project and look forward to a successful launch“, said Larry J. Lapila, President of FPP. The ANDA will be manufactured by Standard. “We are pleased to partner with FPP to launch Riluzole Tablets in the US market and support our shared commitment for reliable and affordable medicines for the benefit of patients”, said Standard.
About Florida Pharmaceutical:
Florida Pharmaceutical Products, LLC. (FPP) is a Boca Raton based pharmaceutical company involved in the development of Generic Pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US.
About Standard:
Standard Chem. & Pharm. Co., Ltd (Standard) is one of the leading pharmaceutical companies in Taiwan. Standard is founded in 1967, and has been a publicly held company since 1995. A vertically integrated pharma with manufacturing capability in API and FDF products, Standard is committed to supplying reliable and high-quality drug products. Standard has been inspected by US-FDA since 2000, and supplying pharmaceutical products in the US for years.
Contact:
Florida Pharmaceutical Products, LLC.
www.flpharmaprducts.com email: [email protected]
Dear Customer:
We are pleased to inform you that Florida Pharmaceutical Products, LLC “FPP”, has completed the acquisition of certain assets of Quinn Pharmaceuticals, LLC, “Quinn”. The JV between FPP and Quinn for Sales, Marketing, and Distribution of the Quinn label in 2019 will now transition over to FPP’s full ownership and all agreements will be assigned to FPP.
All members of the FPP team remain in place and continue to service your account. The operation of the Quinn Label will be maintained under FPP’s ownership. We will continue to provide you with service and support for all of Quinn’s current products, while we prepare to launch the first FPP-labeled products in Q3 2020. There will be no disruption in service of the Quinn product portfolio.
Please note the remittance address below.
All payments should be sent to the FPP offices:
Quinn Pharmaceuticals, c/o FPP
6111 Broken Sound Parkway NW
Suite 160
Boca Raton, FL 33487
FPP continues to add to its pipeline of ANDA’s in both development and licensing. This will assure a steady stream of new generic products in 2020 and beyond.
We are excited to take this next step that the Asset Purchase has created for FPP and Quinn, and also for our Customers. We look forward to continuing to serve your needs.
Sincerely,
Boca Raton, FL / Mumbai, India (April, 1 2020) – Florida Pharmaceutical Products, LLC. (FPP) a pharmaceutical company involved in the Development, Sales, Marketing and Distribution of Generic Pharmaceuticals and Inventia Healthcare Limited (Inventia) a company involved in the Development Manufacturing and Licensing of pharmaceuticals are pleased to announce the signing of an agreement for the Licensing, Supply and Distribution of an ANDA developed by Inventia recently approved by the FDA and scheduled to launch this Summer.
The product has sales of approximately $125 million according to IQVIA™. The ANDA product will be sold and Distributed by FPP in the FPP Label with in the US. “We are excited to work with Inventia on this opportunity and look forward to launching the product “, said Larry J. Lapila, President of FPP. The ANDA will be manufactured by Inventia. ” Inventia is excited to add a new partner to the current portfolio of ANDAs and we are working together with FPP towards a successful launch of the product”, said Ankur J. Shah, Whole-time Director of Inventia.
About Florida Pharmaceutical:
Florida Pharmaceutical Products, LLC. (FPP) is a Boca Raton based pharmaceutical company involved in the development of Generic Pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US.
About Inventia:
Inventia Healthcare Limited is a company headquartered in Mumbai, India; with marketing partners across 28 countries for niche generic oral solid products.
Contact : Florida Pharmaceutical Products, LLC.
www.flpharmaprducts.com email: [email protected]
Inventia Healthcare Limited
https://www.inventiahealthcare.com
To our Valued Partners:
Florida Pharmaceutical Products, LLC (“FPP”), focuses its top priority on the health and well-being of our employees, our trading partners, our business, and in turn, your business. Please rest assured that we are constantly monitoring the everchanging circumstances regarding the pandemic and are following all CDC guidelines as well as state and local directives.
As we chart the course during these evolving times, we have moved to a remote work status. Employees are now working from home. All of our systems and processes remain in place to ensure we meet all of our and your business needs while working remotely. You can continue to reach our team members through usual channels, including the main office and telephone extensions, and email, as well as cell phones if necessary.
Our business is operating normally and the assurance of remaining seamless is critical.
We are pleased to state that, to date, we have not had any continuity issues and all materials are arriving and shipping to customers as scheduled. We have been preparing for these circumstances and will continue to assess the situation daily. We will continue to remain in close contact with not only our suppliers, but our customers as well.
We never lose sight that our business is an “essential” business critical to the Healthcare System and Supply Chain. We distribute medically necessary therapies that support health and well being.
On behalf of everyone at FPP, we send our wishes for good health for you, your employees, family, and friends. Like everyone, we look forward to the COVID-19 pandemic subsiding and returning to business as usual. In the meantime, we must remain fully available to conduct our necessary businesses.
We will reevaluate this policy weekly and take direction from the Federal and Local authorities. We remain primed to react to this fluid situation.
Thank you for the opportunity to serve you,
Florida Pharmaceutical Products, LLC
Quinn Pharmaceuticals, LLC
Florida Pharmaceutical Products, LLC, (FPP)
Florida Pharmaceutical Products, LLC, (FPP), a pharmaceutical company involved in the Development, Sales, Marketing, and Distribution of Generic Pharmaceuticals is pleased to announce the filing of its first organically developed ANDA with the FDA. Currently the market for this product has sales of approximately $100 million according to IQVIA™ and limited generic competition.
This product is one of the original pipeline product selections of the founder, the late Larry Runsdorf. “We are excited about this opportunity and happy to bring this project to filing, in honor of what Larry started several years ago”, said Larry J. Lapila, President of FPP.
About Florida Pharmaceutical Products, LLC:
Florida Pharmaceutical Products, LLC, (FPP), is a Boca Raton-based pharmaceutical company involved in the development of Generic Pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US. At FPP our mission is to deliver products to improve patients’ lives.
Florida Pharmaceutical Products, LLC and Impopharma Canada Limited sign license for niche generic, pending FDA approval.
Florida Pharmaceutical Products, LLC. (FPP) a pharmaceutical company involved in the Development, Sales, Marketing and Distribution of Generic Pharmaceuticals and Ayrton Saunders Ltd. (ASL) a company involved in the Development and Licensing of pharmaceuticals are pleased to announce the signing of an agreement for the licensing of an ANDA developed by ASL’s affiliate company Impopharma Canada Limited, currently filed with the FDA and expected to be approved mid-2020.
The product has sales of approximately $70 million according to IQVIA™ and limited generic competition. The ANDA product will be sold and Distributed by FPP in the FPP Label, once approved. “We are very pleased to have this opportunity and look forward to launching this product next year”, said Larry J. Lapila, President of FPP. The ANDA will be transferred to FPP upon approval and manufactured under a separate agreement by Novocol Pharma, Inc. (NPI) Ontario, Canada.
About Florida Pharmaceutical:
Florida Pharmaceutical Products, LLC. (FPP) is a Boca Raton based pharmaceutical company involved in the development of Generic Pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US.
About Ayrton Saunders:
Ayrton Saunders Limited is a U.K. based company engaged in the development, licensing and commercialization of pharmaceutical products involving aerosol and topical delivery for respiratory, cardiovascular, dermatological and other conditions in conjunction with affiliate and partner companies for markets world-wide. Ayrton Saunders Ltd. and Impopharma Canada Limited are wholly owned subsidiaries of OBG Pharmaceuticals Ltd.
About Novocol:
Novocol Pharma, Inc. is a contract development and manufacturing organization specializing in cartridge based injectables, combination products and unit dose nasal sprays. Novocol operates from its 200,000 square foot manufacturing plant located in Cambridge, Canada, serving US, Canadian and international markets.
Contact:
Florida Pharmaceutical Products, LLC
email: [email protected]
Hauppauge, NY (May 23, 2019) — Hauppauge-based pharmaceutical company Contract Pharmacal Corp. has acquired Florida Pharmaceutical Products, Inc. (FPP), a generic pharmaceutical company focused on R&D, co-development and licensing.
Headed by its president, 35-year industry veteran Larry Lapila, FPP has already inked a variety of partnership agreements in 2019. In January, FPP entered into a partnership with Bluepharma, agreeing to file an ANDA and manage product sales, marketing and distribution within the United States upon FDA approval. In February, the company signed a joint venture agreement to manage sales, marketing and distribution for Quinn Pharmaceuticals, an own-label distributor with commercial products.
“The investment in FPP solidifies CPC’s entrance into the generic Rx market and provides FPP with the capital and manufacturing resources to expand its product portfolio and accelerate growth,” said Matt Wolf, CEO of CPC.
Both companies are privately held, and no terms were disclosed.
Contract Pharmacal Corp.
Contract Pharmacal Corp. (CPC) develops, manufactures and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Owned and operated by the same family that founded the company in 1971, CPC today employs 1,500 of the most highly skilled, experienced professionals in the industry and to date has commercialized more than 4,500 products.
Florida Pharmaceutical Products, Inc.
Florida Pharmaceutical Products, Inc. (FPP) is a Boca Raton, Florida-based pharmaceutical company involved in the development of generic pharmaceuticals, seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US. FPP brings affordably priced prescription medications from development to distribution for the benefit of patients.
For further information, contact:
Contract Pharmacal Corp. at [email protected] or Florida Pharmaceutical Products, Inc. at [email protected].
Boca Raton, FL (March 15, 2019) – Florida Pharmaceutical Products, Inc. (FPP) and Qilu Pharmaceutical Co., Ltd., (Qilu)., two pharmaceutical companies involved in the development manufacturing, sales, marketing and distribution of generic pharmaceuticals announce an agreement for FPP to manage sales, marketing and distribution of Qilu’s ANDA for Tenofovir 300mg Tablets. The product has current sales of $130 million according to IQVIA™.
FPP plans to launch with the Quinn label, taking advantage of the strategic alliance they recently entered, and transition when FPP launches its label.
“We are excited about this opportunity and happy to work with Qilu on this project,” said Larry J. Lapila, President of FPP. “After developing and receiving FDA approval for this product, we are pleased to have partnered with FPP to bring it to the market,” commented Jing Zhang, General Manager of Import & Export Division of Qilu.
About Florida Pharmaceutical:
Florida Pharmaceutical Products, Inc. (FPP) is a Boca Raton based pharmaceutical company involved in the development of generic pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the U.S.
At FPP our mission is to deliver products to improve patients’ lives.
About Qilu:
Qilu Pharmaceutical Co., Ltd., is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing
Contact:
Florida Pharmaceutical Products, Inc.
info@ flpharmaproducts.com
Deal Combines Strengths of Both Companies Creating End-To-End Solution From Procurement to Order Fulfillment; Capitalizing On Opportunities Originating in Asia For U.S. Distribution
(Boca Raton, FL and Irvine, CA; February 4, 2019) — Stason Pharmaceuticals, Inc., a global pharmaceutical group based in Irvine, CA has entered into a strategic alliance with Florida Pharmaceutical Products, Inc., (FPP) for Stason subsidiary Quinn Pharmaceuticals, LLC. Financial terms were not disclosed.
With strong business ties to pharmaceutical interests in Japan, Taiwan and China, Stason Pharmaceuticals, Inc., acquires and develops promising drug candidates originating in Asia and guides their manufacture, sale and distribution within the United States.
Florida Pharmaceutical Products, Inc., based in Boca Raton, FL has experienced leadership with proven deal-closing expertise, a solid implementation track record, influential industry relationships and extensive resources to realize objectives with speed and efficiency.
According to Florida Pharmaceutical Products, Inc., President Larry Lapila, “The structure of this agreement supercharges the flow of generic pharmaceutical drugs from Asia to the United States and utilizes our skillset to create greater production, distribution and supply chain efficiencies for Stason and Quinn.”
Stason Pharmaceuticals, Inc., CEO Harry Fan adds, “The Quinn label, built by the Quinn team under the leadership of Gina Campbell, is recognized for quality and value. The new alliance with Florida Pharmaceutical Products, Inc., creates a continuous all-inclusive solution by fueling manufacturing options and also adding warehousing, logistics and order fulfillment to retail accounts. This framework improves results and provides the infrastructure for continued growth.”
This new arrangement merges capabilities to create an end-to-end solution for generic pharmaceutical development, manufacture, sales, marketing, distribution and supply chain logistics.
Florida Pharmaceutical Products, Inc., recently entered a strategic partnership with Woodfield Distribution, LLC to support FPP business expansion. For further information, contact Larry Lapila, Florida Pharmaceutical Products, Inc., or Gina Campbell, Quinn Pharmaceuticals, Inc., (561) 609-3240 or [email protected].