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5 API Suppliers, 1 USDMF, 2 KDMF, 4 Listed Suppliers, $ API Reference Price

5 API Suppliers
1 USDMF
2 KDMF
4 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

16 FDF Dossiers, 10 Europe, 1 South Africa, 5 Listed Dossiers

16 FDF Dossiers
10 Europe
1 South Africa
5 Listed Dossiers

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15 APIs, 3 FDF Dossiers, 3 EXCIPIENTS

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3 FDF Dossiers
3 EXCIPIENTS

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Synopsis

ACTIVE PHARMA INGREDIENTS

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$ 28

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Chemistry

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Also known as: Sodium alginate, 9005-38-3, Natriumglucuronat, Schembl20919851, Ft-0621962, Ft-0670280

Molecular Formula

C₆H₉NaO₇

Molecular Weight

216.12 g/mol

InChI Key

MSXHSNHNTORCAW-UHFFFAOYSA-M

Salts and esters of ALGINIC ACID that are used as HYDROGELS; DENTAL IMPRESSION MATERIALS, and as absorbent materials for surgical dressings (BANDAGES, HYDROCOLLOID). They are also used to manufacture MICROSPHERES and NANOPARTICLES for DIAGNOSTIC REAGENT KITS and DRUG DELIVERY SYSTEMS.

1 2D Structure

Sodium Alginate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;3,4,5,6-tetrahydroxyoxane-2-carboxylate

2.1.2 InChI

InChI=1S/C6H10O7.Na/c7-1-2(8)4(5(10)11)13-6(12)3(1)9;/h1-4,6-9,12H,(H,10,11);/q;+1/p-1

2.1.3 InChI Key

MSXHSNHNTORCAW-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C1(C(C(OC(C1O)O)C(=O)[O-])O)O.[Na+]

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Alginate

2. Alginate, Barium

3. Alginate, Calcium

4. Alginate, Copper

5. Alginate, Potassium

6. Alginate, Sodium

7. Alginate, Sodium Calcium

8. Alginates

9. Alginic Acid, Barium Salt

10. Alginic Acid, Calcium Salt

11. Alginic Acid, Copper Salt

12. Alginic Acid, Potassium Salt

13. Alginic Acid, Sodium Salt

14. Alloid G

15. Barium Alginate

16. Calcium Alginate

17. Calcium Alginate, Sodium

18. Calginat

19. Copper Alginate

20. Kalrostat

21. Kalrostat 2

22. Kaltostat

23. Poly(mannuronic Acid), Sodium Salt

24. Potassium Alginate

25. Sodium Alginate

26. Sodium Calcium Alginate

27. Vocoloid

28. Xantalgin

2.2.2 Depositor-Supplied Synonyms

1. Sodium Alginate

2. 9005-38-3

3. Natriumglucuronat

4. Schembl20919851

5. Ft-0621962

6. Ft-0670280

7. Sodium;3,4,5,6-tetrahydroxyoxane-2-carboxylate

2.3 Create Date

2005-09-18

3 Chemical and Physical Properties

Molecular Formula	C₆H₉NaO₇
Molecular Weight	216.12 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	1
Exact Mass	216.02459690 g/mol
Monoisotopic Mass	216.02459690 g/mol
Topological Polar Surface Area	130 Å²
Heavy Atom Count	14
Formal Charge	0
Complexity	210
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	5
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Therapeutic Uses

Mesh Heading: Radiation-protective agents, hemostatics, biocompatible materials

National Library of Medicine, SIS; ChemIDplus Record for Algin (9005-38-3). Available from, as of April 17, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

EXPTL USE: Alginate therapy (20 mg Na alginate; 40 mg manucol SS/LD/2) applied immediately after single oral contaminantion with radiostrontium (0.2-0.4 uCi/mL) reduced skeletal retention of radiostrontium.

KADIC M; VETERINARIA (SARAJAVO) 24 (2) 219-34 (1975)

EXPTL USE: Alginated bread fed to mice increased (85)Sr concentration in blood, decreased urinary excretion and increased fecal excretion.

VAN DER BORGHT ET AL; MINER METAB LAB, STUDIECENT KERNENERG CENT ETUDE ENERG NUCL, MOL, BELG

EXPTL USE: Absorption in mice of strontium, barium, and radium was depressed more than that of calcium by alginates tested, include sodium alginate.

HUMPHREYS ET AL; INT CONF STRONTIUM METAB (PAP) 2ND; VOL CONF-720818, 1973, 309-314

For more Therapeutic Uses (Complete) data for ALGIN (8 total), please visit the HSDB record page.

5 Pharmacology and Biochemistry

5.1 Absorption, Distribution and Excretion

Apparently ... not decomposed or absorbed appreciably when ingested ...

Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-155

When propyleneglycol (14)C alginate or (14)C propylene glycol alginate ... dosed to mice, unhydrolyzed ester and alginate residue ... unabsorbed from GI tract; but any hydrolyzed propyleneglycol ... absorbed ... metabolized and eliminated ... single dose ... 1 g/kg ... excreted ... feces ... 5 days ...

The Chemical Society. Foreign Compound Metabolism in Mammals Volume 3. London: The Chemical Society, 1975., p. 343

... After a dose of 5 g/kg, traces of label were still present in rectum. Alginate prepared from laminaria digitata was unabsorbed by rats fed at a level of 10% of their daily diet.

The Chemical Society. Foreign Compound Metabolism in Mammals Volume 3. London: The Chemical Society, 1975., p. 343

API SUPPLIERS

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USDMF

01

Qingdao Bright Moon Seaweed Group Co...

China

Pharma, Lab & Chemical Expo

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Listed Suppliers

01

Inabata France S.A.S

France

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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France

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Sodium Alginate

About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...

Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata-Pharmasynthèse offers a wide range of services, including sourcing, manufacturing, and the development of raw materials for the pharmaceutical and cosmetic industries. It supplies these ingredients to Europe, Japan, and other countries. With expertise in fine chemical production, Inabata-Pharmasynthèse conducts manufacturing operations, ranging from pilot to commercial quantities, at its GMP-certified facility at St. Pierre-Les-Elbeuf in France.

02

Rochem International Inc

U.S.A

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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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U.S.A

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Sodium Alginate

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.

03

Pharm-RX Chemical

U.S.A

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Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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Sodium Alginate

About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...

Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritional supplement, and food industries. The company maintains an exceptionally selective approach to its suppliers, personally visiting manufacturers overseas to ensure the highest standards. The sustained growth of Pharm-Rx can be attributed to its steadfast commitment to three core values: quality ingredients, competitive pricing, and unparalleled customer service.

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Innova Remedies

India

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Europe

01

Pharmactive ilac

Turkey

Pharmatech Expo 2025

Not Confirmed

02

Nobel Ilac Sanayii Ve Ticaret A.S.

Turkey

Pharmatech Expo 2025

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03

Nobel Ilac Sanayii Ve Ticaret A.S.

Turkey

Pharmatech Expo 2025

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RECKITT BENCKISER HEALTHC.Ltd

United Kingdom

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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.

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APIs

USP/ BP Grade Sodium Alginate (600 kg - 700 kg) API needed in India [ENA20512]

A company that focuses on manufacturing of tablets, capsules & oral liquids is looking for suppliers of USP/ BP Grade Sodium Alginate (600 kg - 700 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

10 Sep 2024

BP/ EP Grade Sodium Alginate (100 kg) API needed in United Kingdom [ENA20133]

A company that focuses on manufacturing and distribution of various finished formulations is looking for suppliers of BP/ EP Grade Sodium Alginate (100 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

30 Jul 2024

Injectable Grade Sodium Alginate (MOQ) API needed in South Korea [ENA17485]

A company that deals in the distribution of active ingredients, excipients & intermediates is looking for suppliers of Injectable Grade Sodium Alginate (MOQ) API for commercial purposes. The suppliers must support this enquiry with CoA.

07 Jul 2023

Various APIs needed in India [ENA16865]

A CMO that focuses on solid & liquid finished formulations in various therapeutic areas is looking for suppliers of Various APIs for commercial purposes. The required quantity is 1 MT for each. The suppliers must support this enquiry with CoA. 1. IP Grade Levocarnitine API 2. IP Grade Pancreatin API 3. IP Grade Thiocolchicoside (8 mg) SR Pellets 4. IP Grade Sodium Alginate API

11 Apr 2023

Sodium Alginate (10 MT) API needed in Bangladesh [ENA15405]

A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Sodium Alginate (10 MT) API for commercial purpose. The suppliers must support this enquiry with CoA.

28 Oct 2022

Various APIs needed in Algeria [ENA15025]

A company that focuses on the development, marketing & sales of pharmaceutical products and cosmetics is looking for suppliers of Various APIs for development purpose. The suppliers must support this enquiry with CoA. 1. Camomile Flower Extract 2. Valerian Root Extract 3. Propolis Extract 4. Sodium Alginate API

13 Sep 2022

BP Grade Sodium Alginate (400 kg) API needed in Sri Lanka [ENA14733]

A company that deals in the distribution of various pharmaceutical products is looking for suppliers of BP Grade Sodium Alginate (400 kg) API for commercial purpose. The suppliers must support this enquiry GMP & CoA.

19 Aug 2022

Various APIs needed in Philippines [ENA14237]

A company that aims to become a global leader as a manufacturer of health care products by providing solutions is looking for suppliers of Various APIs for development purpose. The suppliers must support this enquiry with GMP & CoA. 1. Ascorbic Acid (10 kg) API 2. Divalproex Sodium (1 kg) API 3. Sodium Alginate (5 kg) API

06 Jul 2022

Sodium Alginate & Tamsulosin HCl APIs needed in Slovenia [ENA12621]

A contract manufacturing organization that deals in the production of high-quality products is looking for suppliers of Sodium Alginate & Tamsulosin HCl APIs. The suppliers must support this enquiry with CoA.

05 Feb 2022

Various APIs needed in Vietnam [ENA10766]

DSL Global, a company that deals in manufacturing, trading, importing and exporting of pharmaceutical products is looking for suppliers of various APIs. The suppliers must support this enquiry with DMF or CEP, GMP & CoA. Interested suppliers can contact them via their email: lientran@dslglobalvn.com. 1. D-alpha-tocopherol (7 kg) API 2. L-Arginine L-Glutamate (3 MT) API 3. Sodium Alginate (500 kg) API 4. Lovastatin (20 kg) API 5. Misoprostol (100 g) API 6. Attapulgite (2.5 MT) API 7. Bromelain (100 g) API 8. Calciferol (100 g) API

02 Jul 2021

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FDF DOSSIERS

Sodium Alginate (10 ml) Oral Liquid Packs needed in Ukraine [ENA17732]

A company that focuses on manufacturing of various finished formulations is looking for suppliers of Sodium Alginate (10 ml) Oral Liquid Packs for commercial purposes. The required quantity is 15,000 units. The suppliers must support this enquiry with Dossier.

02 Aug 2023

Sodium Alginate Oral Suspensions needed in Thailand [ENA14300]

A company that focuses in marketing and distribution of various finished formulations is looking for suppliers of Sodium Alginate (500 mg) + Sodium Bicarbonate (213 mg) + Calcium Carbonate (325 mg) Oral Suspensions in 150 ml bottles or 10 ml Sachets for commercial purpose. The suppliers must support this enquiry with ACTD dossier.

11 Jul 2022

Looking for CTD Dossiers of Paracetamol (300 mg) Syrup & Sodium Alginate (500 mg) Sachet [ENA09042]

A pharmaceutical company providing consultations for new & existing pharmaceuticals projects is looking for CTD Dossiers of Paracetamol (300 mg) Syrup & Sodium Alginate (500 mg) Sachet for the Algerian market.

12 Nov 2020

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EXCIPIENTS

Various Excipient needed in Germany [ENA19046]

A CMO that focuses on manufacturing and packaging of soft gum is looking for suppliers of various excipients for development purposes. The supplier must support this enquiry with EU Food Law, USFDA & CoA. 1. Acesulfame Potassium (0.1 kg) Excipient 2. Sodium Alginate (0.25 kg) Excipient 3. Sodium Chloride (0.5 kg) Excipient 4. Sucralose (0.1 kg) Excipient 5. Ammonium Chloride (0.1 kg) Excipient 6. Hydroxypropyl Methylcellulose (1 kg) Excipient 7. Carbopol 934 (1 kg) Excipient

15 Feb 2024

Various Excipients needed in India [ENA17124]

A company with 75 years of experience in developing, manufacturing & supplying of herbal extracts is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. Food Grade Cellulose Microcrystalline 200 G & 400 G (CAS 9004-34-6) Excipient. The required quantity is 1 kg & 2 kg. 2. Food Grade Sodium Alginate Excipient. The required quantity is 250 g. 3. Food Grade Xylitol Excipient. The required quantity is 250 g.

18 May 2023

Carbomer, Sodium Bisulfite and other Excipients needed in Thailand [ENA03649]

A quality-centered pharmaceutical company in Thailand is looking for suppliers of below excipients: 1. Carbomer 974P 2. Sodium Bisulfite 3. Opaglos clear (13.3% solid) 4. Oleyl Alcohol 5. Neotame 6. Low-substituted Hydroxypropyl Cellulose (HP-55) 7. Macrogol Cetostearyl 8. Sodium Alginate (BP) 9. Cocoyl Caprylocaprate 10. Diacetylated Monoglycerides 11. Glycol Montanate (Montan Glycol wax) 12. Hypromellose Phthalate

12 Mar 2019

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REF. STANDARDS & IMPURITIES

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Others

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USP

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ABOUT THIS PAGE

Sodium Alginate Manufacturers

A Sodium Alginate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Alginate, including repackagers and relabelers. The FDA regulates Sodium Alginate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Alginate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Sodium Alginate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sodium Alginate Suppliers

A Sodium Alginate supplier is an individual or a company that provides Sodium Alginate active pharmaceutical ingredient (API) or Sodium Alginate finished formulations upon request. The Sodium Alginate suppliers may include Sodium Alginate API manufacturers, exporters, distributors and traders.

click here to find a list of Sodium Alginate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Sodium Alginate USDMF

A Sodium Alginate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Alginate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Alginate DMFs exist exist since differing nations have different regulations, such as Sodium Alginate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sodium Alginate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Alginate USDMF includes data on Sodium Alginate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Alginate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sodium Alginate suppliers with USDMF on PharmaCompass.

Sodium Alginate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Sodium Alginate Drug Master File in Korea (Sodium Alginate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium Alginate. The MFDS reviews the Sodium Alginate KDMF as part of the drug registration process and uses the information provided in the Sodium Alginate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Sodium Alginate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sodium Alginate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Sodium Alginate suppliers with KDMF on PharmaCompass.

Sodium Alginate GMP

Sodium Alginate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Sodium Alginate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sodium Alginate GMP manufacturer or Sodium Alginate GMP API supplier for your needs.

Sodium Alginate CoA

A Sodium Alginate CoA (Certificate of Analysis) is a formal document that attests to Sodium Alginate's compliance with Sodium Alginate specifications and serves as a tool for batch-level quality control.

Sodium Alginate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Alginate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Sodium Alginate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Alginate EP), Sodium Alginate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Alginate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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