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CHEMISTRY

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INACTIVE PHARMA INGREDIENTS

18 Suppliers, 18 USDMF, 22 Listed Suppliers

18 Suppliers
18 USDMF
22 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

2217 FDF Dossiers Suppliers, 112 FDA Listed Dossiers

2217 FDF Dossiers Suppliers
112 FDA Listed Dossiers

EXCIPIENTS BY APPLICATIONS

15 Fillers, Diluents & Binders, 9 Direct Compression, 6 Co-Processed Excipients, 4 Disintegrants & Superdisintegrants, 3 Taste Masking, 3 Chewable & Orodispersible Aids, 2 Controlled & Modified Release, 2 Thickeners and Stabilizers, 1 Coating Systems & Additives, 1 Granulation

15 Fillers, Diluents & Binders
9 Direct Compression
6 Co-Processed Excipients
4 Disintegrants & Superdisintegrants
3 Taste Masking
3 Chewable & Orodispersible Aids
2 Controlled & Modified Release
2 Thickeners and Stabilizers
1 Coating Systems & Additives
1 Granulation

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

1 DATA COMPILATION #PharmaFlow

MARKET PLACE

1 APIs, 14 EXCIPIENTS

1 APIs
14 EXCIPIENTS

Chemistry

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SUPPLIERS

01

Hunan ErKang Pharmaceutical Co Ltd

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

02

Anhui Sunhere Pharmaceutical Excip...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

03

Shivangan Food and Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

04

Micro Pellet

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

05

GRAIN PROCESSING CORP

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

06

Bluecraft Agro

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

07

Japan Corn Starch Co. LTD

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

08

S D Fine Chem Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

09

Maple Biotech

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

10

Colorcon Limited

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

01

Asahi Kasei Corp

Japan

PharmaVenue

Not Confirmed

02

Asahi Kasei Corp

Japan

PharmaVenue

Not Confirmed

03

Colorcon

U.S.A

PharmaVenue

Not Confirmed

04

Grain Processing Corp

U.S.A

PharmaVenue

Not Confirmed

05

Hunan Er Kang Pharmaceutical Co Ltd

China

PharmaVenue

Not Confirmed

06

Ingredion Inc

U.S.A

PharmaVenue

Not Confirmed

07

Ingredion Inc

U.S.A

PharmaVenue

Not Confirmed

08

Japan Corn Starch Co Ltd

Japan

PharmaVenue

Not Confirmed

09

Micropellet

India

PharmaVenue

Not Confirmed

10

Crest Cellulose Private Ltd

France

PharmaVenue

Not Confirmed

Only 10 entries up to this point, click to access all

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FINISHED DOSAGE FORMULATIONS

Upload your portfolio for free, ask us

FDF DOSSIERS SUPPLIERS

01

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

HYDROCHLOROTHIAZIDE; IRBESARTAN

Drug : AVALIDE

Dosage Form : TABLET; ORAL

Application Number : 20758

Country : US

Patented : No

Portfolio PDF

Product Web Link

02

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

IRBESARTAN

Drug : AVAPRO

Dosage Form : TABLET; ORAL

Application Number : 20757

Country : US

Patented : No

Portfolio PDF

Product Web Link

03

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

CLOMIPHENE CITRATE

Drug : CLOMID

Dosage Form : TABLET; ORAL

Application Number : 16131

Country : US

Patented : No

Portfolio PDF

Product Web Link

04

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

MEPENZOLATE BROMIDE

Drug : CANTIL

Dosage Form : SOLUTION; ORAL

Application Number : 10679

Country : US

Patented : No

Portfolio PDF

Product Web Link

05

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

MEPENZOLATE BROMIDE

Drug : CANTIL

Dosage Form : TABLET; ORAL

Application Number : 10679

Country : US

Patented : No

Portfolio PDF

Product Web Link

06

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

PRIMAQUINE PHOSPHATE

Drug : PRIMAQUINE

Dosage Form : TABLET; ORAL

Application Number : 8316

Country : US

Patented : No

Portfolio PDF

Product Web Link

07

SANOFI AVENTIS US

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

TERIFLUNOMIDE

Drug : AUBAGIO

Dosage Form : TABLET; ORAL

Application Number : 202992

Country : US

Patented : Yes

Portfolio PDF

Product Web Link

08

ABBVIE

U.S.A

Duphat

Not Confirmed

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TRANDOLAPRIL

Drug : MAVIK

Dosage Form : TABLET; ORAL

Application Number : 20528

Country : US

Patented : No

Product Web Link

Corporate PDF

09

ABBVIE

U.S.A

Duphat

Not Confirmed

DIVALPROEX SODIUM

Drug : DEPAKOTE

Dosage Form : TABLET, DELAYED RELEASE; ORAL

Application Number : 18723

Country : US

Patented : No

Product Web Link

Corporate PDF

10

ABBVIE

U.S.A

Duphat

Not Confirmed

SUCRALFATE

Drug : CARAFATE

Dosage Form : TABLET; ORAL

Application Number : 18333

Country : US

Patented : No

Product Web Link

Corporate PDF

Only 10 entries up to this point, click to access all

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FDA Listed Dossiers

01

Dosage Form : TABLET

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

02

Dosage Form : TABLET

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

03

Dosage Form : INJECTION

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

04

Dosage Form : CAPSULE

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

05

Dosage Form : CAPSULE, COATED, HARD GELATIN

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

06

Dosage Form : CAPSULE, DELAYED ACTION

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

07

Dosage Form : CAPSULE, ENTERIC COATED PELLET...

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

08

Dosage Form : CAPSULE, HARD GELATIN

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

09

Dosage Form : CAPSULE, SOFT GELATIN

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

10

Dosage Form : CAPSULE, SUSTAINED ACTION

STARCH

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

EXCIPIENTS BY APPLICATIONS

Click here to find the perfect excipient manufacturers by their capabilities

Fillers Diluents Binders

01

Faran Shimi Pharmaceutical

Iran

PharmaVenue

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Pregelatinized Corn Starch

Application : Fillers, Diluents & Binders

Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.

Pharmacopoeia Ref : BP/USP

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

02

Gangwal Healthcare

India

PharmaVenue

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Maize Starch

03

Gangwal Healthcare

India

PharmaVenue

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : DiCOM-DC® PL009 P60

Application : Fillers, Diluents & Binders

Excipient Details : DiCOM-DC PL009 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IH

Technical Specs : NA

Ingredient(s) : Maize Starch

04

Gangwal Healthcare

India

PharmaVenue

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : DiCOM-DC® SP204

Application : Fillers, Diluents & Binders

Excipient Details : DiCOM-DC SP204 is used as a stabilizer, filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

05

Gangwal Healthcare

India

PharmaVenue

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : DiCOM-DC® S-Star

Application : Fillers, Diluents & Binders

Excipient Details : DiCOM-DC S-Star (Maize Starch) is used as a filler, binder, and directly compressible co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Maize Starch

06

Gangwal Healthcare

India

PharmaVenue

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Innogel 9000/9500

Application : Fillers, Diluents & Binders

Excipient Details : Innogel 9000/9500 (Pregelatinized Starch) is used as filler, binder, disintegrant, and superdisintegrant in tablets and capsules.

Pharmacopoeia Ref : IP/BP/EP/USP-NF

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

07

Pluviaendo

Turkey

PharmaVenue

Not Confirmed

08

Ingredion Pharma Solutions

U.S.A

PharmaVenue

Not Confirmed

09

Shanghai Shenmei Pharmaceutical Te...

China

PharmaVenue

Not Confirmed

10

Anhui Sunhere Pharmaceutical Excip...

China

PharmaVenue

Not Confirmed

Only 10 entries up to this point, click to access all

Direct Compression

Co Processed Excipients

Disintegrants Superdisintegrants

01

Gangwal Healthcare

India

Duphat

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Disintegrants & Superdisintegrants

Brand Name : Innogel 9000/9500

Application : Disintegrants & Superdisintegrants

Excipient Details : Innogel 9000/9500 (Pregelatinized Starch) is used as filler, binder, disintegrant, and superdisintegrant in tablets and capsules.

Pharmacopoeia Ref : IP/BP/EP/USP-NF

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

02

Anhui Sunhere Pharmaceutical Excip...

China

Duphat

Not Confirmed

03

Roquette

France

Duphat

Not Confirmed

04

Roquette

France

Duphat

Not Confirmed

Taste Masking

Chewable Orodispersible Aids

Controlled Modified Release

Thickeners And Stabilizers

Coating Systems Additives

Granulation

01

Ingredion Pharma Solutions

U.S.A

PharmaVenue

Not Confirmed

Digital Content

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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.