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    Looking for Lactose Monohydrate pharmaceutical excipients? Find information on Lactose Monohydrate's applications, manufacturers, suppliers, etc. on PharmaCompass.

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

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    FAMAR CDMO- From early development to commercial manufacturing.

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    INACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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    SUPPLIERS

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    01

    Gangwal Healthcare

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32957

    Submission : 2018-07-18

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Gangwal Healthcare CB

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    02

    Dawning Pharmaceuticals

    China

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

    ELCC
    Not Confirmed
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    Dawning Pharmaceuticals

    China

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

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    ELCC
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37267

    Submission : 2022-09-15

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    International Ingredients & Excipi...

    India

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

    ELCC
    Not Confirmed
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    International Ingredients & Excipi...

    India

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

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    ELCC
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37688

    Submission : 2022-11-12

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Meggle

    Germany

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

    ELCC
    Not Confirmed
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    Meggle

    Germany

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

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    ELCC
    Not Confirmed
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20568

    Submission : 2007-05-10

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Meggle

    Germany

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

    ELCC
    Not Confirmed
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    Meggle

    Germany

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

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    ELCC
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28498

    Submission : 2014-05-23

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Lactose India Limited

    India

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

    ELCC
    Not Confirmed
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    Lactose India Limited

    India

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

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    ELCC
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38990

    Submission : 2023-10-16

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Kerry

    U.S.A

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

    ELCC
    Not Confirmed
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    Kerry

    U.S.A

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

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    ELCC
    Not Confirmed
    USDMF Inactive-api
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21598

    Submission : 2008-05-07

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Kerry

    U.S.A

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

    ELCC
    Not Confirmed
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    Kerry

    U.S.A

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

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    ELCC
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24141

    Submission : 2010-09-14

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    FINISHED DOSAGE FORMULATIONS

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    FDA Listed Dossiers

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    01

    Dosage Form : INJECTION

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : INJECTION

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : IM - IV

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 2.5

    Potency Unit : %

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    02

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : IM - IV

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 2.5

    Potency Unit : %

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    03

    Dosage Form : POWDER, FOR INJECTION SOLUTION...

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION...

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : INTRAMUSCULAR

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 1.05

    Potency Unit : %

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    04

    Dosage Form : INJECTION

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : INJECTION

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 25

    Potency Unit : %

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    05

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LACTOSE MONOHYDRATE
    arrow
    BIO-Europe Spring
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
    arrow
    BIO-Europe Spring
    Not Confirmed

    • fda
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    LACTOSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 75

    Potency Unit : %

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    06

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LACTOSE MONOHYDRATE
    arrow
    BIO-Europe Spring
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
    arrow
    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : IV(INFUSION)

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 20

    Potency Unit : %

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    07

    Dosage Form : CAPSULE

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : CAPSULE

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 430.42

    Potency Unit : MG

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    08

    Dosage Form : CAPSULE, HARD GELATIN

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : CAPSULE, HARD GELATIN

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 141

    Potency Unit : MG

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    09

    Dosage Form : CAPSULE, SUSTAINED ACTION

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : CAPSULE, SUSTAINED ACTION

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 147.6

    Potency Unit : MG

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    10

    Dosage Form : GRANULE, FOR SUSPENSION

    LACTOSE MONOHYDRATE
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    BIO-Europe Spring
    Not Confirmed

    Dosage Form : GRANULE, FOR SUSPENSION

    USA
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    BIO-Europe Spring
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 0

    Potency Unit : NA

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    Only 10 entries up to this point, click to access all click full view read-more
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    EXCIPIENTS BY APPLICATIONS

    Click here to find the perfect excipient manufacturers by their capabilities

    Fillers Diluents Binders

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    Granulation

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    01

    Kerry

    U.S.A
    ELCC
    Not Confirmed
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    02

    DFE Pharma

    Germany
    ELCC
    Not Confirmed
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    03

    Kerry

    U.S.A
    ELCC
    Not Confirmed
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    04

    Kerry

    U.S.A
    ELCC
    Not Confirmed
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    05

    Sigachi Industries

    India
    ELCC
    Not Confirmed
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    06

    Microlex e.U

    Austria
    ELCC
    Not Confirmed
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    07

    Microlex e.U

    Austria
    ELCC
    Not Confirmed
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    Direct Compression

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    01

    Kerry

    U.S.A
    ELCC
    Not Confirmed
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    02

    Kerry

    U.S.A
    ELCC
    Not Confirmed
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    03

    Sigachi Industries

    India
    ELCC
    Not Confirmed
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    04

    Microlex e.U

    Austria
    ELCC
    Not Confirmed
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    05

    Microlex e.U

    Austria
    ELCC
    Not Confirmed
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    Co Processed Excipients

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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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    EXCIPIENTS

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    Various Excipients needed in India [ENA24717]
    A company that focuses on the manufacturing of pharmaceutical products is looking for suppliers of Various Excipients for development purposes. The suppliers must support this enquiry with CoA. 1. Croscarmellose Sodium Excipient 2. Microcrystalline Cellulose Excipient 3. Lactose Monohydrate Excipient 4. Colloidal Silicon Dioxide Excipient 5. Magnesium Stearate Excipient
    03 Dec 2025

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    03 Dec 2025

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    03 Dec 2025

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    Various Excipients needed in India [ENA22797]
    A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CEP & CoA. 1. EP /BP Grade Magnesium Stearate Excipient 2. EP /BP Grade Talc Excipient 3. EP /BP Grade Polyvinylpyrrolidone Excipient 4. EP /BP Grade Maize Starch Excipient 5. EP /BP Grade Lactose monohydrate Excipient 6. EP /BP Grade Isopropyl alcohol Excipient
    28 Apr 2025

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    28 Apr 2025

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    Reply Comment (3)

    28 Apr 2025

    Nigeria.png
    Various Excipients needed in Nigeria [ENA21630]
    A company that focuses on manufacturing of various finished formulations is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. Lactose Monohydrate (3 MT) Excipient 2. Dextrose Monohydrate (20 MT) Excipient 3. Maize Starch (5 MT) Excipient
    03 Jan 2025

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    03 Jan 2025

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    Reply Comment (7)

    03 Jan 2025

    india-flag.png
    Lactose Monohydrate (5 kg) Excipient needed in India [ENA21581]
    A company that focuses on manufacturing of various finished formulations is looking for suppliers of Lactose Monohydrate (5 kg) Excipient for development purposes. The suppliers must support this enquiry with CoA.
    28 Dec 2024

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    28 Dec 2024

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    Reply Comment (4)

    28 Dec 2024

    india-flag.png
    Various Excipients needed in India [ENA21024]
    A company that focuses on manufacturing of various general and oncology active pharmaceutical ingredients is looking for suppliers of IP Grade Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. Microcrystalline Cellulose Excipient 2. Lactose Monohydrate Excipient 3. Sodium Starch Glycolate Excipient 4. Hydroxypropylmethylcellulose Excipient 5. Sodium Lauryl Sulfate Excipient 6. Magnesium Stearate Excipient 7. Lactose Anhydrous Excipient 8. Croscarmellose Sodium Excipient
    04 Nov 2024

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    04 Nov 2024

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    Reply Comment (8)

    04 Nov 2024

    Indonesia.png
    Lactose Monohydrate (50 MT/ annum) Excipient needed in Indonesia [ENA19789]
    A company specializing in the production of various prescription medications, over-the-counter (OTC) products, and veterinary medicines for both domestic and international markets is looking for suppliers of Lactose Monohydrate (50 MT/ annum) Excipient for commercial purposes. The supplier must support this enquiry with open & closed part DMF & CoA
    24 Jun 2024

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    24 Jun 2024

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    Reply Comment (6)

    24 Jun 2024

    india-flag.png
    Various Excipient needed in India [ENA19671]
    A company that specializes in manufacturing various finished formulations across various therapeutic areas is looking for suppliers of Various Excipients for commercial purposes. The supplier must support this enquiry with CoA. 1. BP Grade Methylene Dichloride (400 kg) Excipient 2. BP Grade Lactose Monohydrate (175 kg) Excipient 3. BP Grade Mannitol Crystalline (75 kg) Excipient 4. BP Grade Crospovidone (75 kg) Excipient 5. BP Grade PVP K-30 (50 kg) Excipient 6. BP Grade Calcium Stearate (25 kg) Excipient 7. BP Grade Pregelatinised Starch (25 kg) Excipient 8. BP Grade Microcrystalline Cellulose (500 kg) Excipient
    10 Jun 2024

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    10 Jun 2024

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    Reply Comment (3)

    10 Jun 2024

    Egypt.png
    Lactose Monohydrate (150 mesh & 80 mesh) Excipient needed in Egypt [ENA19165]
    A company that focuses on manufacturing of various finished formulations of veterinary is looking for suppliers of Lactose Monohydrate (150 mesh & 80 mesh) Excipient for commercial purposes. The required quantity is 6,000 kg. The supplier must support this enquiry with CoA.
    08 Mar 2024

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    08 Mar 2024

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    Reply Comment (7)

    08 Mar 2024

    Iran.png
    Lactose Monohydrate (20 MT) Excipient needed in Iran [ENA18905]
    A company that focuses on trading of various pharmaceutical products is looking for suppliers of Lactose Monohydrate (20 MT) Excipient for commercial purposes. The supplier must support this enquiry with CoA.
    15 Jan 2024

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    15 Jan 2024

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    Reply Comment (13)

    15 Jan 2024

    Mexico.png
    USP Grade Lactose Monohydrate Excipient needed in Mexico [ENA18640]
    A company that focuses on distribution of various pharmaceutical products is looking for suppliers of USP Grade Lactose Monohydrate Excipient. The required quantity is 316 Tons/ annum. The suppliers must support this enquiry with CoA.
    17 Nov 2023

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    17 Nov 2023

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    Reply Comment (10)

    17 Nov 2023

    Only 10 entries up to this point, click to access all click full view read-more
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    XYZ Pharma

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    XYZ Pharma

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    Lactose Monohydrate (500 mg)

    CAS Number : 64044-51-5

    Quantity Per Vial : 500

    Sale Unit : mg

    Price : $290.00

    Details : Material Origin- Animal-Cow; USMCA- No; KORUS...

    Monograph :

    Storage :

    Code/Batch No : Catalog #1356701 / R084R0

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