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    Gangwal Plot N-5 In Boisar, Palghar, India Receives Excipact GMP Certification

    10 Jul 2023

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    The nutrition industry is fast catching up with pharma by way of regulations, quality and clinical trials

    25 Jul 2022

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    Gangwal Healthcare to set up unit for manufacturing nutraceuticals

    29 Jan 2022

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    Gangwal Healthcare – a solutions provider for Complex, Innovative & Cutting-edge technological formulations!
    The building of a "best-in-class" solution provider starts with understanding the complexities of a customer's needs and identifying gaps. New technologies and Drug Delivery Systems are studied, and appropriate excipients are identified to resolve the problem. Working closely with our customers for over 35 years, Gangwal has made this possible due to a team of highly technical and marketing professionals with decades of experience in problem-solving.

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    705, Quantum Tower, Rambagh Lane, Behind State Bank Of India, Malad (west), Mu...
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    +91 2228888567
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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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    https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

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    Gangwal Plot N-5 In Boisar, Palghar, India Receives Excipact GMP Certification
    Gangwal Plot N-5 In Boisar, Palghar, India Receives Excipact GMP Certification

    10 Jul 2023

    // PRESS RELEASE

    https://www.pharmacompass.com/pdf/news/gangwal-plot-n-5-in-boisar-palghar-india-receives-excipact-gmp-certification-93713.pdf

    PRESS RELEASE
    10 Jul 2023
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    The nutrition industry is fast catching up with pharma by way of regulations, quality and clinical trials
    The nutrition industry is fast catching up with pharma by way of regulations, quality and clinical trials

    25 Jul 2022

    // ET HEALTH

    https://health.economictimes.indiatimes.com/news/industry/the-nutrition-industry-is-fast-catching-up-with-pharma-by-way-of-regulations-quality-and-clinical-trials-anil-jain-gangwal-healthcare/93042953

    ET HEALTH
    25 Jul 2022
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    Gangwal Healthcare to set up unit for manufacturing nutraceuticals
    Gangwal Healthcare to set up unit for manufacturing nutraceuticals

    29 Jan 2022

    // THE HINDU

    https://www.thehindu.com/business/gangwal-healthcare-to-set-up-unit-for-manufacturing-nutraceuticals/article38346256.ece

    THE HINDU
    29 Jan 2022
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    KEY PRODUCTS

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    Drug Product Manufacturing

    Discover their expertise for : Drug Product Manufacturing

    Excipients

    Discover the DDS // excipients from this company

    All Excipients

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    01

    Hydroxypropyl Betacyclodextrin

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.
    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23816

    Submission : 2010-05-15

    Status : Active

    Type : IV

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

    Product
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    02

    Lactose Monohydrate

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
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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

    Product
    Web Link

    Stock Recap
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    03

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33081

    Submission : 2018-08-16

    Status : Active

    Type : IV

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

    Product
    Web Link

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    04

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33609

    Submission : 2019-02-26

    Status : Active

    Type : IV

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

    Product
    Web Link

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    05

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33625

    Submission : 2019-02-27

    Status : Active

    Type : IV

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

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    06

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33656

    Submission : 2019-03-13

    Status : Active

    Type : IV

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

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    07

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33751

    Submission : 2019-04-04

    Status : Active

    Type : IV

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

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    08

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33804

    Submission : 2019-04-17

    Status : Active

    Type : IV

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

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    Web Link

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    09

    Microcrystalline Cellulose

    India

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33848

    Submission : 2019-05-15

    Status : Active

    Type : IV

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

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    Stock Recap
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    10

    Microcrystalline Cellulose

    India

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34087

    Submission : 2019-08-19

    Status : Active

    Type : IV

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

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

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    01

    Brand Name : Complexol B®

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    Dosage Form : Capsule, Emulsion, Suspension, Syrup, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Solubilizers, Taste Masking, Thickeners and Stabilizers

    Excipient Details : Complexol-B (Beta-Cyclodextrin) is used as a solubilizer, stabilizer & taste masking agent in oral syrups, suspensions, emulsions, tablets & capsules.

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

    Technical Specs : NA

    Ingredient(s) : Beta-Cyclodextrin

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    Gangwal Healthcare Complexol B®
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    02

    Brand Name : Complexol HP®

    India
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    Antibody Engineering
    Not Confirmed
    • fda
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    Dosage Form : Capsule, Emulsion, Injectable / Parenteral, Ophthalmic Solution, Solution, Suspension, Syrup, Tablet

    Grade : Oral, Parenteral

    Gangwal Healthcare

    Application : Controlled & Modified Release, Parenteral, Solubilizers, Taste Masking, Thickeners and Stabilizers

    Excipient Details : Complexol-HP (Hydroxypropyl Betacyclodextrin) is used as stabilizer, solubilizer & taste masking agent in solids, liquids, ophthalmics & injectables.

    Pharmacopoeia Ref : BP/EP/USP-NF

    Technical Specs : NA

    Ingredient(s) : Hydroxypropyl Betacyclodextrin

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    Gangwal Healthcare Complexol HP®
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    03

    Brand Name : CutCal®

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Suspension, Syrup, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Taste Masking

    Excipient Details : CutCal (Neotame) is used as an artificial sweetener in oral solid & liquid dosage forms such as tablets, capsules, syrups, suspensions, and emulsions.

    Pharmacopoeia Ref : IP/USP-NF

    Technical Specs : NA

    Ingredient(s) : Neotame

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    Gangwal Healthcare CutCal®
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    04

    Brand Name : DiCOM-DC® PL009 P60

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Co-Processed Excipients, Direct Compression, 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; Microcrystalline Cellulose

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    Gangwal Healthcare DiCOM-DC® PL009 P60
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    05

    Brand Name : DiCOM-DC® S-Star

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Co-Processed Excipients, Direct Compression, 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

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    Gangwal Healthcare DiCOM-DC® S-Star
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    06

    Brand Name : DiCOM-DC® S604

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : DiCOM-DC S604 is used as a DC co-processed excipient with a combination of various polymers that act as fillers and binders in tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : Polyvinyl Pyrrolidone 97% & 93%

    Ingredient(s) : Calcium Carbonate Excipient; Polyvinyl pyrrolidone

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    Gangwal DiCOM-DC® S604
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    07

    Brand Name : DiCOM-DC® SP204

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

    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; Magnesium Oxide Excipient; Microcrystalline Cellulose; Sodium Starch Glycolate

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    Gangwal Healthcare DiCOM-DC® SP204
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    08

    Brand Name : DiCOM-DC® SR300

    India
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    Antibody Engineering
    Not Confirmed
    • fda
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    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

    Excipient Details : DiCOM-DC SR300 is used as a directly compressible, rate-controlling, and co-processed excipient in sustained-release tablets and capsules.

    Pharmacopoeia Ref : In-house

    Technical Specs : NA

    Ingredient(s) : EthylCellulose; Hydroxypropyl Cellulose; Hydroxypropyl Methylcellulose; Magnesium Stearate; Maize Starch; Microcrystalline Cellulose; Silicon Dioxide; Talc

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    Gangwal Healthcare DiCOM-DC® SR300
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    09

    Brand Name : Gellets-P®

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Granule / Pellet, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Controlled & Modified Release

    Excipient Details : Gellets-P are Microcrystalline Cellulose based spheres for the manufacturing of pellets and modified release products.

    Pharmacopoeia Ref : In-house

    Technical Specs : NA

    Ingredient(s) : Microcrystalline Cellulose

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    Gangwal Healthcare Gellets-P®
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

    10

    Brand Name : Innogel 9000/9500

    India
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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Disintegrants & Superdisintegrants, 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

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    Innogel 9000/9500
    Antibody Engineering
    Not Confirmed

    Excipients Web Link

    Market Place

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    Gangwal Healthcare is a supplier offers 13 products (APIs, Excipients or Intermediates).

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