SPI Pharma, Inc. DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Enhancing Patient Experience UltraBurst™The Ultimate ODT Solution

03 Feb 2025

// PRESS RELEASE

Beyond Pharma: SPI Pharma’s Impact Across Industries

11 Dec 2024

// PRESS RELEASE

SPI Pharma & Inimmune to Develop &Commercialize Vaccine Adjuvant

17 Jul 2024

// PR NEWSWIRE

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

CPhI North America

Attending

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

1 Vlog #PharmaReel, 42 Corporate Content #SupplierSpotlight, 1 Data Compilation #PharmaFlow, 30 News #PharmaBuzz

media
1 Vlog #PharmaReel
42 Corporate Content #SupplierSpotlight
1 Data Compilation #PharmaFlow
30 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

31 All APIs, 2 USDMF, 4 CEP/COS, 29 NDC API

31 All APIs
2 USDMF
4 CEP/COS
29 NDC API

EXCIPIENTS

7 All Excipients, 7 USDMF, 33 Listed Products

excipientPortfolio
7 All Excipients
7 USDMF
33 Listed Products

KEY EXCIPIENTS

Pharmasperse 416, Advantol 300, Advantose 100, Advantose FS95, Compressol SM, Lubripharm SSF, Mannogem Granular, Mannogem Powder, Mannogem XL Mannitol, Pharmaburst 500, Mannogem EZ, MS90, CS90, CM90, Mannogem® XL Ruby, Mannogem® XL Opal, Mannogem® Onyx, Mannogem® Emerald, DC CoDried, DC Calcium Carbonate, Vitasmooth®, DC SIM 100, AHMC 0600, AHMC 0611, Mannogem 2080

EXCIPIENTS BY INGREDIENTS

Mannitol, Aluminum Hydroxide Excipient, Magnesium Hydroxide Excipient, Calcium Carbonate Excipient, Starch, Magnesium Carbonate Excipient, Sorbitol, Tartaric Acid, Maltodextrin Excipient, Simethicone Excipient, Fructose, Sodium Stearyl Fumarate, Microcrystalline Cellulose, Sodium Bicarbonate Excipient, Maltose Sugar, Sorbitan Excipient

excipientsByIngredients
Mannitol
Aluminum Hydroxide Excipient
Magnesium Hydroxide Excipient
Calcium Carbonate Excipient
Starch
Magnesium Carbonate Excipient
Sorbitol
Tartaric Acid
Maltodextrin Excipient
Simethicone Excipient
Fructose
Sodium Stearyl Fumarate
Microcrystalline Cellulose
Sodium Bicarbonate Excipient
Maltose Sugar
Sorbitan Excipient

EXCIPIENTS BY APPLICATIONS

Chewable & Orodispersible Aids, Direct Compression, Taste Masking, Fillers, Diluents & Binders, Co-Processed Excipients, Disintegrants & Superdisintegrants, Granulation, Solubilizers, API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Film Formers & Plasticizers, Lubricants & Glidants, Thickeners and Stabilizers

excipientsByApplications
Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Fillers, Diluents & Binders
Co-Processed Excipients
Disintegrants & Superdisintegrants
Granulation
Solubilizers
API Stability Enhancers
Coating Systems & Additives
Controlled & Modified Release
Film Formers & Plasticizers
Lubricants & Glidants
Thickeners and Stabilizers

INSPECTIONS & REGISTRATIONS

12 FDA, 17 EDQM, 3 GDUFA

inspections
12 FDA
17 EDQM
3 GDUFA

SPI Pharma has been solving formulation challenges using superior functional materials.

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.

CPhI North America CPhI North America

Industry Trade Show

Attending

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
CPhI ChinaCPhI China

Industry Trade Show

Booth #E3D40

24-26 June, 2025

SNIEC, Shanghai, China
World Vaccine CongressWorld Vaccine Congress

Industry Trade Show

Attending

13-16 October, 2025

RAI Congress Centre, Amsterdam

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

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

Telephone

+1 8007899755

salesinfo@spipharma.com

Website

https://www.spipharma.com/en/

https://www.linkedin.com/company/spi-pharma_2/

YouTube

https://www.youtube.com/channel/UCOJxMkxrSEdYbQxdQYAg92Q

Digital content

Explore the latest content creation from this company

VLOG #PharmaReel

Solving Formulation Challenges with Superior Functional Material

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

Open PDF

Upload

Corporate Presentation

GMP Certificate 2024

Sorbitol Special®

SIM 100 DC Simethicone Powder

Pharmasperse® 416

Pharmaburst® 500

Magnesium Hydroxide Powders

Open PDF

Upload

Magnesium Hydroxide Pastes

Open PDF

Upload

Mannogem® XL Mannitol

Mannogem® Mannitol

Lubripharm® SSF Sodium Stearyl Fumarate

Open PDF

Upload

Effer-Soda® Sodium Bicarbonate

Open PDF

Upload

Directly Compressible Sugars

Open PDF

Upload

Compressol® SM Co Processed Polyol

Open PDF

Upload

CoBlend Grades Aluminum & Magnesium Hydroxide

Open PDF

Upload

AHMH 3535 Aluminum & Magnesium Hydroxide

Open PDF

Upload

Advantose® FS95 Directly Compressible Fructose

Open PDF

Upload

Advantose® 100 Maltose Powder

Advantol® 300

Orally Dispersible Technologies

Vaccine Adjuvants

Actimask® Taste Masked Actives

Open PDF

Upload

Distribution Partnership between SPI Pharma & Ingredientpharm

Pharmasolutions

Corporate Video

Pharmasperse® ODP Platform

Effer-Soda for Effervescents

Vaccine Adjuvants

GERD Awareness Week

Introducing Mannogem® XL Opal

Mannogem® Emerald & Onyx

Mannogem® XL Ruby

MS90 for Supplement Tablets

UltraBurst™

UltraBurst™ - Flash ODT Platform

Vitasmooth® DC Calcium Carbonate

Making a Difference in Your Formulation

Pharmaburst® 500-ODT Platform

Pharmasolutions

Effer-Soda®

DATA COMPILATION #PharmaFlow

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.