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    Looking for excipients offered by SPI Pharma? Find information on SPI Pharma's regulatory filings (DMFs), cGMP inspections, pricing availability, etc. on PharmaCompass.

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    SPI Pharma & Inimmune to Develop &Commercialize Vaccine Adjuvant

    17 Jul 2024

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    Embracing Patient-Centric Formulations for a Healthier Tomorrow

    08 Jan 2024

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    Offering broader access to sustainable pharma-grade saponin adjuvants

    13 Oct 2023

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    About

    For over 75 years, SPI Pharma has been supplying highly engineered products and innovative solutions to the pharmaceutical and nutritional industries to improve the formulation and delivery of drug products to meet patient needs. Owned by Associated British Foods, SPI Pharma has established itself as a global leader, serving over 55 countries in the manufacture and marketing of antacid actives, specialty excipients, drug delivery systems and taste-masking technology for solid oral and oral dispersible dosage forms.

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    Rockwood Office Park, 503 Carr Rd., Suite 210, Wilmington, DE 19809
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    Product List 2023

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    Corporate Presentation

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    GMP Certificate 2023

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    Sorbitol Special®

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    SIM 100 DC Simethicone Powder

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    Pharmasperse® 416

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    Pharmaburst® 500

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    Magnesium Hydroxide Powders

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    Magnesium Hydroxide Pastes

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    Mannogem® XL Mannitol

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    Mannogem® Mannitol

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    Lubripharm® SSF Sodium Stearyl Fumarate

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    Effer-Soda® Sodium Bicarbonate

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    Directly Compressible Sugars

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    Compressol® SM Co Processed Polyol

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    CoBlend Grades Aluminum & Magnesium Hydroxide

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    AHMH 3535 Aluminum & Magnesium Hydroxide

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    Advantose® FS95 Directly Compressible Fructose

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    Advantose® 100 Maltose Powder

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    Advantol® 300

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    Orally Dispersible Technologies

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    Vaccine Adjuvants

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    Actimask® Taste Masked Actives

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    Distribution Partnership between SPI Pharma & Ingredientpharm

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    Pharmasolutions

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    DATA COMPILATION #PharmaFlow

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    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   
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    NEWS #PharmaBuzz

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    SPI Pharma & Inimmune to Develop &Commercialize Vaccine Adjuvant
    SPI Pharma & Inimmune to Develop &Commercialize Vaccine Adjuvant

    17 Jul 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/spi-pharma-inc-and-inimmune-corp-partner-to-develop-and-commercialize-innovative-vaccine-adjuvant-systems-302198093.html

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    17 Jul 2024
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    Embracing Patient-Centric Formulations for a Healthier Tomorrow
    Embracing Patient-Centric Formulations for a Healthier Tomorrow

    08 Jan 2024

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    https://www.spipharma.com/en/insights-and-events/news-blog/embracing-patient-centric-formulations-for-a-healthier-tomorrow/

    PRESS RELEASE
    08 Jan 2024
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    Offering broader access to sustainable pharma-grade saponin adjuvants
    Offering broader access to sustainable pharma-grade saponin adjuvants

    13 Oct 2023

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    https://www.spipharma.com/en/insights-and-events/news-blog/offering-broader-access-to-sustainable-and-scalable-pharma-grade-saponin-adjuvants/

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    13 Oct 2023
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    SPI Pharma In Grand Haven Receives Excipact Gmp Certification As Pharma Excipient Supplier
    SPI Pharma In Grand Haven Receives Excipact Gmp Certification As Pharma Excipient Supplier

    10 Jul 2023

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    https://www.excipact.org/news-reader/spi-pharma-in-grand-haven-usa-receives-excipact-gmp-certification-as-pharmaceutical-excipient-supplier.html

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    10 Jul 2023
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    SPI Pharma Announces signing of Regional Sole Distribution Agreement for ACTILLETS™ MCC
    SPI Pharma Announces signing of Regional Sole Distribution Agreement for ACTILLETS™ MCC

    09 Mar 2023

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    https://www.pharmacompass.com/pdf/news/spi-pharma-inc-announces-signing-of-regional-sole-distribution-agreement-for-actillets-mcc-microcrystalline-cellulose-pellets-tap-tartaric-acid-pellets-and-directly-compressible-ibuprofen-dc100-with-ingredientpharm-84886.pdf

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    09 Mar 2023
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    CPHI Frankfurt 2022 SPI Pharma is attending CPHI Frankfurt on Nov 1st to 3rd
    CPHI Frankfurt 2022 SPI Pharma is attending CPHI Frankfurt on Nov 1st to 3rd

    01 Nov 2022

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    https://www.spipharma.com/en/news-and-events/events/cphi-frankfurt-2022/

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    01 Nov 2022
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    Excipients

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    CALCIUM CARBONATE DC TYPE CS...

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21367

    Submission : 2008-02-27

    Status : Active

    Type : II

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    PHARMABURST(TM) C1

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17044

    Submission : 2003-12-22

    Status : Active

    Type : IV

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    PHARMABURST® 500 AND SL SER...

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24099

    Submission : 2010-08-27

    Status : Active

    Type : IV

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    PHARMABURST® 530

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28402

    Submission : 2014-06-18

    Status : Active

    Type : IV

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    PHARMABURST® B SERIES PRODU...

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16037

    Submission : 2002-07-03

    Status : Active

    Type : IV

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    SODIUM BICARBONATE PRODUCTS

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20389

    Submission : 2007-03-30

    Status : Active

    Type : IV

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    ULTRABURST

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37133

    Submission : 2022-08-17

    Status : Active

    Type : IV

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    Inspections and registrations

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    GMP Certified

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    Type : GMP Certificates

    Number : HMP/FR/54/2...

    EudraGMDP Key : 10042

    Country : France

    Issue Date : 2011-02-16

    Post Code : 13240

    NCA Ref : 417 890 910 ...

    City : SEPTEMES LES VALLONS

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    GMP Certified

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    Type : GMP Certificates

    Number : VMP/FR/3/20...

    EudraGMDP Key : 10036

    Country : France

    Issue Date : 2011-02-16

    Post Code : 13240

    NCA Ref : 417 890 910 ...

    City : SEPTEMES LES VALLONS

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    GMP Certified

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    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4592

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

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    GMP Certified

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    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4580

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

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    GMP Certified

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    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4618

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

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    GMP Certified

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    SPI Pharma

    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4535

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

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    GMP Certified

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    SPI Pharma

    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4556

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

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    GMP Certified

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    SPI Pharma

    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4562

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

    SPI Pharma

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    09

    GMP Certified

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    CPhI India 2024
    Booth #8.Q31

    SPI Pharma

    Type : GMP Certificates

    Number : 2008/HMP/PT...

    EudraGMDP Key : 4554

    Country : U.S.A

    Issue Date : 2008-07-22

    Post Code : 19958

    NCA Ref : 417 890 910 ...

    City : LEWES

    SPI Pharma

    Product
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    Stock Recap
    #PipelineProspector

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    10

    GMP Certified

    EU
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    CPhI India 2024
    Booth #8.Q31

    SPI Pharma

    Type : GMP Certificates

    Number : 2008/HMP/FR...

    EudraGMDP Key : 4376

    Country : France

    Issue Date : 2008-05-07

    Post Code : 13240

    NCA Ref : 417 890 910 ...

    City : SEPTEMES LES VALLONS

    SPI Pharma

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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    SPI Pharma is a supplier offers 4 products (APIs, Excipients or Intermediates).

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