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    Company profile for Gangwal Healthcare

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

    10 Jul 2023

    // PRESS RELEASE

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

    25 Jul 2022

    // ET HEALTH

    Gangwal Healthcare to set up unit for manufacturing nutraceuticals

    29 Jan 2022

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    About

    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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    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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    12 Sep 2024
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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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    ALL APIs

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    01

    Isoxsuprine Hydrochloride

    India

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26857

    Submission : 2013-01-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-07-08

    Valid Till : 2024-11-04

    Written Confirmation Number : WC-0432

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Gangwal Healthcare CB

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    02

    Salmeterol Xinafoate

    India

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26863

    Submission : 2013-02-04

    Status : Active

    Type : II

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

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    03

    Timolol Maleate

    India

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

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    USDMF CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-07-08

    Valid Till : 2024-11-04

    Written Confirmation Number : WC-0432

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Gangwal Healthcare CB

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    Web Link

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    04

    Formoterol Fumarate

    India

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

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

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    05

    Modafinil

    India

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

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    06

    Palmitoylethanolamide

    India

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

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    Gangwal Healthcare CB

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    KEY PRODUCTS

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    Services

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    Drug Product Manufacturing

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    Excipients

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    USDMF

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    01

    ACESULFAME POTASSIUM USP

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39527

    Submission : 2024-02-08

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    02

    BETADEX USP

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39536

    Submission : 2024-02-14

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    03

    CROSCARMELLOSE SODIUM USP

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37534

    Submission : 2022-09-27

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

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    04

    DIRECTLY COMPRESSIBLE MANNIT...

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41204

    Submission : 2025-01-15

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    05

    HYDROXYPROPYL BETADEX

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23816

    Submission : 2010-05-15

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    06

    SODIUM STARCH GLYCOLATE USP

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37083

    Submission : 2022-04-28

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    07

    SODIUM STEARYL FUMARATE USP ...

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37309

    Submission : 2022-07-12

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    08

    STARLOSE CO-PROCESSED GRANUL...

    India
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    Gangwal Healthcare

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32957

    Submission : 2018-07-18

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

    09

    SUCRALOSE USP

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25112

    Submission : 2011-07-08

    Status : Active

    Type : IV

    Gangwal Healthcare CB

    Excipients Web Link

    Market Place

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    Listed Products

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    01

    Brand Name : Complexol-B®

    India
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    Dosage Form : Tablet, Capsule

    Grade : Oral

    Gangwal Healthcare

    Application : API Stability Enhancers, Solubilizers

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

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

    Technical Specs : NA

    Ingredient(s) : Beta-Cyclodextrin

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    Gangwal Healthcare Complexol-B®
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    02

    Brand Name : Complexol-HP®

    India
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    Dosage Form : Tablet, Cream / Lotion / Ointment, Injectable / Parenteral, Ophthalmic Solution

    Grade : Oral, Parenteral, Topical, Ophthalmic

    Gangwal Healthcare

    Application : API Stability Enhancers, Solubilizers

    Excipient Details : Complexol-HP (HP-beta-CD) is a water-soluble derivative of beta cyclodextrin, used as a solubilizer & complexing agent in pharmaceutical formulations.

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

    Technical Specs : NA

    Ingredient(s) : Hydroxypropyl Betacyclodextrin

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    Gangwal Healthcare Complexol-HP®
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    03

    Brand Name : Cutcal™

    India
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    Dosage Form : Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Taste Masking

    Excipient Details : Cutcal (Neotame) is used as a sweetener and a taste masking agent in oral dosage forms such as tablets.

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

    Technical Specs : NA

    Ingredient(s) : Neotame

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    Gangwal Healthcare Cutcal™
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    04

    Brand Name : Lubristar™

    India
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    Dosage Form : Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Lubricants & Glidants

    Excipient Details : Lubristar is used as a lubricant in oral dosage forms such as tablets.

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, PSD, DMF, ...

    Technical Specs : NA

    Ingredient(s) : Sodium Stearyl Fumarate

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    Gangwal Healthcare Lubristar™
    CPhI South East Asia
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    05

    Brand Name : Microlose™

    India
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    Dosage Form : Tablet

    Grade : Oral

    Gangwal Healthcare

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

    Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.

    Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...

    Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

    Ingredient(s) : Lactose Monohydrate; Microcrystalline Cellulose

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    Gangwal Healthcare Microlose™
    CPhI South East Asia
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    06

    Brand Name : Mpressol™

    India
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    Dosage Form : Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Fillers, Diluents & Binders

    Excipient Details : Mpressol (Mannitol) is a polyol used as a filler in tablet formulations, sugar-free solutions and as a bulking agent in freeze-dried products.

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

    Technical Specs : NA

    Ingredient(s) : Mannitol

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    Gangwal Mpressol™
    CPhI South East Asia
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    07

    Brand Name : ProBlend®

    India
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    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

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

    Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.

    Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...

    Technical Specs : NA

    Ingredient(s) : Silicified Microcrystalline Cellulose

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    Gangwal Healthcare ProBlend®
    CPhI South East Asia
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    Brand Name : Sallyso™

    India
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    CPhI South East Asia
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    Dosage Form : Capsule, Orodispersible Tablet, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Disintegrants & Superdisintegrants

    Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

    Technical Specs : Sallyso 0.5 to 3.0%

    Ingredient(s) : Croscarmellose Sodium

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    Gangwal Healthcare Sallyso™
    CPhI South East Asia
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    Brand Name : Solvostar™

    India
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    CPhI South East Asia
    Attending
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    • EDQM
    • WHO-GMP

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    Dosage Form : Capsule, Tablet

    Grade : Oral

    Gangwal Healthcare

    Application : Disintegrants & Superdisintegrants

    Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant in oral solid dosage forms such as tablets and capsules.

    Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

    Technical Specs : Solvostar 2% to 8%

    Ingredient(s) : Sodium Starch Glycolate

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    Gangwal Healthcare Solvostar™
    CPhI South East Asia
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    Brand Name : Sorbiplast®

    India
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    CPhI South East Asia
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Dosage Form : Softgels

    Grade : Oral

    Gangwal Healthcare

    Application : Film Formers & Plasticizers

    Excipient Details : Sorbiplast (Sorbitol Sorbitan Solution) acts as a plasticizer in the production of soft gelatin capsules, enhancing its flexibility & stability.

    Pharmacopoeia Ref : USP-NF, BP, EP, DMF, EXCiPAT, ...

    Technical Specs : NA

    Ingredient(s) : Sorbitol

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    Gangwal Healthcare Sorbiplast®
    CPhI South East Asia
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    Excipients Web Link

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    Gangwal Healthcare is a supplier offers 6 products (APIs, Excipients or Intermediates).

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