Commercial Manufacturing

Commercial Manufacturing
Product Description

Covering a 135,000ft² area, our Miami facility is registered with the FDA and complies fully with current good manufacturing practice (cGMP) guidelines. It has the capacity for R&D, process development and small-scale launches, including pilot-scale cGMP manufacturing and packaging to support pilot pharmacokinetic (PK) studies.




The facility offers a full selection of oral solid dosage forms, including modified release dosage forms and enteric-coated tablets. It can produce extended-release tablets using both wet and dry granulation techniques, and design drug delivery systems for poorly soluble compounds.




Avéma has the capacity to produce up to six billion tablets and capsules a year, as well as a wide range of products for both oral dose and liquid dose, including small-volume, high-potency compounds and small-molecule compounds

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Avema Contract Servies

  • US
  • 2017
    On CPHI since
  • 1
    Certificates
Company types
Contract Service
View company profile
Categories
more categories Show less

Avema Contract Servies

  • US
  • 2017
    On CPHI since
  • 1
    Certificates
Company types
Contract Service
View company profile

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Avema Contract Servies resources (12)

  • Lessons Learned: Choosing & Managing a CDMO

    Brochure Lessons Learned: Choosing & Managing a CDMO

    Lessons Learned: Choosing & Managing a CDMOAvéma Pharma Solutions, a division of PL Developments (PLD), is in the unique position being both a consumer and supplier of global CDMO services for both OTC and rX products. In this presentation, we’ll explore the lessons we have learned from managing our own CMOs that have allowed us to build a better CDMO model for our Avéma customers. We’ll address the areas that can help speed up your time-to-market, keep development costs under control, and smooth the FDA approval and commercial launch process. Watch our webinar at https://app.webinar.net/K2OlZE6JLx9?mcc=WebsitePost
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    Video Welcome to Avema Contract Services

    Avéma Contract Services is one of the only Contract Development and Manufacturing Organization (CDMO) that offers integrated, turnkey, end-to-end solutions for Rx, OTC and nutraceutical liquid and solid dose delivery systems. Headquartered in Westbury, NY, Avéma has manufacturing and distribution locations in Miami, Fla., Lynwood, Ca., and Greenville, S.C. Avéma Contract Services is powered by PL Developments.
    2021-08-02
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    Video Overcoming the Challenges of Gummies as a Drug Delivery System

    The global gummy vitamin market is expected to reach 10.6 billion by 2025 and gummies are gaining traction as a drug delivery system -- especially for children and seniors who resist taking pills, capsules and liquids. Mitchell Slade, who brings more than 20 years of gummy manufacturing experience at Nature’s Bounty to the table, will address the challenges of developing gummies beyond supplements, such ensuring consistent dosage, production and taste. Avéma/PLD has a world-class GDUFA facility that is CFR 211 and CFR 111 certified, uses a starchless gummy manufacturing process and brings 40+ years of formulating experience to the development of innovative drug delivery systems.
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    The global gummy vitamin market is expected to reach 10.6 billion by 2025 and gummies are gaining traction as a drug delivery system -- especially for children and seniors who resist taking pills, capsules and liquids. Mitchell Slade, who brings more than 20 years of gummy manufacturing experience at Nature’s Bounty to the table, will address the challenges of developing gummies beyond supplements, such ensuring consistent dosage, production and taste. Avéma/PLD has a world-class GDUFA facility that is CFR 211 and CFR 111 certified, uses a starchless gummy manufacturing process and brings 40+ years of formulating experience to the development of innovative drug delivery systems.
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    Brochure The Promise of Gummies as a Drug Delivery System

    Avéma is leveraging its OTC and Rx drug development expertise into using gummies as a novel delivery system. This White Paper describes what it takes to succeed in this expanding market.
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    Brochure Avéma Pharma Solutions: Capabilities

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    Looking at the supplement industry as a barometer for drug delivery systems, it’s apparent that gummies are gaining traction as a preferred delivery system. In 2019, the sales of non-pill formats, including gummies, powders and shots, exceeded the sales of pill formats and that gap between the pill and non-pill market share continues to grow.
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    Avéma Pharma Solutions is building an enhanced, state-of-the-art R&D center that is almost three times larger than the existing space and will help the company respond to increased customer demand for formulation and analytical development.
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  • Take a tour of Avéma's R&D facilities.

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    Aaron Dely, Avéma's Senior Director of Global Research, gives a tour of Avéma's R&D facilities and discusses how the company's focus on small batches with short turn times around allows for more characterization of the process through design of experiments to support the FDA’s mandate on quality by design. This approach can lead to reductions in review time by the FDA and lead to fewer information requests or a faster approval cycle.
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