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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Synopsis

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Chemistry

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Also known as: 25655-41-8, Povidone-iodine, Betadine, Isodine, Pvp iodine, Pvp-iodine

Molecular Formula

C₆H₉I₂NO

Molecular Weight

364.95 g/mol

InChI Key

CPKVUHPKYQGHMW-UHFFFAOYSA-N

An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.

1 2D Structure

Povidone-Iodine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-ethenylpyrrolidin-2-one;molecular iodine

2.1.2 InChI

InChI=1S/C6H9NO.I2/c1-2-7-5-3-4-6(7)8;1-2/h2H,1,3-5H2;

2.1.3 InChI Key

CPKVUHPKYQGHMW-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C=CN1CCCC1=O.II

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Alphadine

2. Alphadines

3. Betadine

4. Betadines

5. Betaisodona

6. Disadine

7. Disadines

8. Isodine

9. Isodines

10. Pharmadine

11. Pharmadines

12. Polyvinylpyrrolidone Iodine

13. Polyvinylpyrrolidone Iodines

14. Povidone-iodine

15. Povidone-iodines

16. Providine

17. Providines

18. Pvp Iodine

19. Pvp-i

20. Pvp-iodine

21. Pvp-iodines

2.2.2 Depositor-Supplied Synonyms

1. 25655-41-8

2. Povidone-iodine

3. Betadine

4. Isodine

5. Pvp Iodine

6. Pvp-iodine

7. Pvp-i

8. Isobetadyne

9. Bridine

10. Disphex

11. Povadyne

12. Ultradine

13. Efo-dine

14. Iodopoly(vinyl Pyrrolidinone)

15. 1-ethenylpyrrolidin-2-one;molecular Iodine

16. Nsc26245

17. 2-pyrrolidinone, 1-ethenyl-, Homopolymer, Compd. With Iodineother Ca Index Names:iodine, Compd. With 1-ethenyl-2-pyrrolidinone Homopolymer

18. Iodine-poly(vinylpyrrolidinone)

19. Poly(vinylpyrrolidinone) Iodide

20. Iodinated Poly(vinylpyrrolidone)

21. Poly(vinylpyrrolidone)-iodine Adduct

22. Poly(vinylpyrrolidinone)-iodine Complex

23. Poly(vinylpyrrolidone) - Iodine Complex

24. Polyvinylpyrrolidone Compound With Iodine

25. Povidone.iodine

26. 1-ethenyl-2-pyrrolidinone Homopolymer Compound With Iodine

27. Molecular Iodine; 1-vinylpyrrolidin-2-one

28. 1-ethenylpyrrolidin-2-one; Molecular Iodine

29. Povidone Iodine-ip, 9-12%

30. Schembl1652685

31. Bcp28568

32. Nsc28655

33. Mfcd00084483

34. Nsc-26245

35. Nsc-28655

36. Akos015898248

37. Polyvinylpyrrolidone-iodinecomplex

38. 1-ethenyl-2-pyrrolidinone; Molecular Iodine

39. Ft-0655804

40. 2-pyrrolidinone, Polymers, Compd. With Iodine

41. A16118

42. 2-pyrrolidinone, Homopolymer, Compd. With Iodine

43. A817952

44. Q241516

45. 1-vinylpyrrolidin-2-one Compound With Diiodine (1:1)

46. Poly[1-(2-oxo-1-pyrrolidinyl)ethylene]iodine Complex

47. Povidone (iodinated), European Pharmacopoeia (ep) Reference Standard

2.3 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₆H₉I₂NO
Molecular Weight	364.95 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	1
Exact Mass	364.87736 g/mol
Monoisotopic Mass	364.87736 g/mol
Topological Polar Surface Area	20.3 Å²
Heavy Atom Count	10
Formal Charge	0
Complexity	120
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Betadine
PubMed Health	Povidone Iodine (Into the eye)
Drug Classes	Antiseptic
Drug Label	Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas:2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:BETADINE 5% Ster...
Active Ingredient	Povidone-iodine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	5%
Market Status	Prescription
Company	Alcon Pharms

2 of 4
Drug Name	Povidone iodine
PubMed Health	Povidone Iodine (Into the eye)
Drug Classes	Antiseptic
Drug Label	Other InformationStore below 98F/37C avoid direct heat and sunlight...
Active Ingredient	Povidone-iodine
Dosage Form	Solution
Route	Topical
Strength	1%
Market Status	Over the Counter
Company	Allegiance Hlthcare

3 of 4
Drug Name	Betadine
PubMed Health	Povidone Iodine (Into the eye)
Drug Classes	Antiseptic
Drug Label	Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas:2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:BETADINE 5% Ster...
Active Ingredient	Povidone-iodine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	5%
Market Status	Prescription
Company	Alcon Pharms

4 of 4
Drug Name	Povidone iodine
PubMed Health	Povidone Iodine (Into the eye)
Drug Classes	Antiseptic
Drug Label	Other InformationStore below 98F/37C avoid direct heat and sunlight...
Active Ingredient	Povidone-iodine
Dosage Form	Solution
Route	Topical
Strength	1%
Market Status	Over the Counter
Company	Allegiance Hlthcare

4.2 Therapeutic Uses

Anti-Infective Agents, Local

National Library of Medicine's Medical Subject Headings online file (MeSH, 2014)

Povidone-iodine is an iodophore that is used as a disinfectant and antiseptic mainly for the treatment of contaminated wounds and pre-operative preparation of the skin and mucous membranes as well as for disinfection of equipment.

SWEETMAN, S.C. (ed.) Martindale-The Complete Drug Reference. 36th ed. London: The Pharmaceutical Press, 2009., p. 1659

BETADINE 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).

NIH; DailyMed. Current Medication Information for BETADINE- povidone-iodine solution (Revised: July 2011). Available from, as of October 14, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b026de1b-9949-4557-ac49-c7b0038c24cd

4.3 Drug Warning

No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption.

Because of the potential for serious adverse reactions in nursing infants from BETADINE 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

For external use only. Not for intraocular injection or irrigation.

For more Drug Warnings (Complete) data for Povidone-iodine (9 total), please visit the HSDB record page.

4.4 Drug Indication

For topical application in the treatment and prevention of infection in wounds.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Povidone iodine is a kind of iodine disinfectant which directly cause in vivo protein denaturation, precipitation of bacteria, and further resulting in the death of pathogenic microorganisms. Therefore, it is effective in disinfection and sterilization. It can kill viruses, bacteria, spores, fungi, and protozoa with low toxicity to human. Povidone-iodine aqueous solution has strong pharmacological activity against Staphylococcus aureus, Neisseria gonorrhoeae, Pseudomonas aeruginosa, syphilis, hepatitis B virus, HIV, and Trichomonas vaginalis. Povidone iodine gel is a gynecological topical semi-mobile colloidal agent made by povidone iodine and hydrophilic matrix. It is a system for maintaining its sustained release. Owing to the continuous release of free iodine, it can enable the skin and mucous membranes to maintain a certain effective concentration of iodine for killing bacteria. It is mainly used for gynecological vaginal infection. It exerted its effect through being miscible with vaginal secretions and further killing the inside pathogenic microorganisms, and thus blocking the spread of sexually transmitted diseases and invasion, as well as treating other infected vaginal diseases caused by other kinds of bacteria. Published reports on the in vitro antimicrobial efficacy of iodophors demonstrate that iodophors are bactericidal, mycobactericidal, and virucidal but can require prolonged contact times to kill certain fungi and bacterial spores. Three brands of povidone-iodine solution have demonstrated more rapid kill (seconds to minutes) of S. aureus and M. chelonae at a 1:100 dilution than did the stock solution. The virucidal activity of 75150 ppm available iodine was demonstrated against seven viruses. Other investigators have questioned the efficacy of iodophors against poliovirus in the presence of organic matter and rotavirus in distilled or tapwater. Manufacturers' data demonstrate that commercial iodophors are not sporicidal, but they are tuberculocidal, fungicidal, virucidal, and bactericidal at their recommended use-dilution.

5.2 MeSH Pharmacological Classification

Anti-Infective Agents, Local

Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects. (See all compounds classified as Anti-Infective Agents, Local.)

5.3 ATC Code

D - Dermatologicals

D08 - Antiseptics and disinfectants

D08A - Antiseptics and disinfectants

D08AG - Iodine products

D08AG02 - Povidone-iodine

D - Dermatologicals

D09 - Medicated dressings

D09A - Medicated dressings

D09AA - Medicated dressings with antiinfectives

D09AA09 - Povidone-iodine

D - Dermatologicals

D11 - Other dermatological preparations

D11A - Other dermatological preparations

D11AC - Medicated shampoos

D11AC06 - Povidone-iodine

G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AX - Other antiinfectives and antiseptics

G01AX11 - Povidone-iodine

R - Respiratory system

R02 - Throat preparations

R02A - Throat preparations

R02AA - Antiseptics

R02AA15 - Povidone-iodine

S - Sensory organs

S01 - Ophthalmologicals

S01A - Antiinfectives

S01AX - Other antiinfectives

S01AX18 - Povidone-iodine

5.4 Absorption, Distribution and Excretion

Absorption

Povidone-Iodine is intended for topical application and is not absorbed.

Route of Elimination

Povidone-Iodine is intended for topical application and is not eliminated.

Volume of Distribution

Povidone-Iodine is intended for topical application and has no volume of distribution.

Clearance

Povidone-Iodine is intended for topical application and is not eliminated.

Topical application of povidone iodine on the umbilical cord and normal intact skin of newborn infants resulted in significantly elevated plasma iodine levels. High iodine levels were also found in two neonates who had povidone iodine applied to denuded skin. No significant alteration in thyroid function was seen. The possible toxic manifestations of high plasma iodine levels are discussed.

PMID:909027 Pyati SP et al; J Pediatr. 91 (5): 825-8 (1977)

In 12 nonpregnant women, total iodine, protein-bound iodine, inorganic iodine, and thyroxine values were measured in serum before and 15, 30, 45 or 60 minutes after a two-minute vaginal disinfection with povidone-iodine (Betadine). Only 15 minutes after application, serum iodine levels were raised and remained significantly elevated 30, 45 and 60 minutes after disinfection. Serum concentrations of total iodine and inorganic iodine were increased up to fivefold to 15-fold, respectively; during the relative short period of observation, thyroxine levels were not altered.

PMID:7431610 Vorherr H et al; JAMA. 244 (23): 2628-9 (1980)

5.5 Metabolism/Metabolites

Povidone-Iodine is not absorbed or metabolized.

5.6 Biological Half-Life

Povidone-Iodine is intended for topical application and is not eliminated.

5.7 Mechanism of Action

Povidone-iodine is called iodophore which means povidone acts as a carrier of iodine. Iodine is considered as the active moiety that mediates microbicidal actions. When released from the complex, free iodine (I2) penetrates the cell wall of microorganisms quickly, and the lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis. While the full mechanism of action is not fully elucidated, iodine is thought to inhibit vital bacterial cellular mechanisms and structures, and oxidizes nucleotides fatty or amino acids in bacterial cell membranes. Additionally, free iodine disrupts the function of the cytosolic enzymes involved in the respiratory chain, causing them to become denatured and deactivated. _In vitro_ evidence suggests that iodine also counteracts inflammation elicited by both pathogens and the host response via multifactorial effects. In hosts, povidone-iodine was demonstrated to modulate the redox potential, inhibit the release of inflammatory mediators such as TNF- and -galactosidase, inhibit metalloproteinase production, and potentiate the healing signals from pro-inflammatory cytokines by activation of monocytes, T-lymphocytes, and macrophages, _in vitro_.

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FDF DOSSIERS

Tender// Various Finished Dosage Formulations needed in Poland [ENA15305]

Centrum Leczenia Oparzen im. dr. Stanislawa Sakiela w Siemianowicach slaskich is looking for supplies of Various Finished Dosage Formulations for commercial purposes. The deadline is 18-Oct-2022. 1. Enoxaparin Sodium (40 mg/ 0.4 ml) Injections. The required quantity is 500 units. 2. Povidone-Iodine (45 mg/ ml) Solution. The required quantity is 350 units.

13 Oct 2022

Polyvinylpyrrolidone (10%) Solutions needed in Canada [ENA12062]

A company that deals in the distribution of various medical products is looking for suppliers of Polyvinylpyrrolidone (10%) Solutions for commercial purpose. The required quantity is 1,200 units. The required pack size is 500 ml bottles.

09 Dec 2021

Tender// Various Finished Dosage Formulations needed in Poland [ENA10961]

27 Jul 2021

Tender// Various Finished Dosage Formulations needed by Administrative Tribunal of Public Procurement in Spain [ENA08933]

Administrative Tribunal of Public Procurement, a department based in Spain is looking for suppliers of Various Finished Dosage Formulations. Interested suppliers can visit the link:https://ted.europa.eu/udl?uri=TED:NOTICE:474786-2020:TEXT:EN:HTML&tabId=1 1. Amoxicillin (500 mg) Tablets 2. Amoxicillin (500 mg) + Clavulanic (125 mg) Tablets 3. Ceftriaxone (500 mg) Injection 4. Dexchlorpheniramine (5 mg) injection 5. Ibuprofen (20 mg/ml in 200 ml) Suspension 6. Mepivacaine (30 mg/ml) injection 7. Methylprednisolone (20 mg & 40 mg) Injection 8. Morphine (10 mg/ml in 1 ml) Injection 9. Octreotide (100 mcg/ ml in 1 ml) Injection 10. Povidone Iodine (10 %) Liquid 11. Paracetamol (150 mg) Suppository 12. Prednisone (10 mg & 30 mg) Tablet 13. Tobramycin (3 mg/ml) 5 ml Eye Drops

29 Oct 2020

Tender// Various Finished Dosage Formulations needed by Satu Mare Pneumoftiziology Hospital in Romania [ENA08877]

Satu Mare Pneumoftiziology Hospital, based in Romania is looking for the Various Finished Dosage Formulations. Interested suppliers can visit the link: https://ted.europa.eu/udl?uri=TED:NOTICE:474619-2020:TEXT:EN:HTML&tabId=0 1. Allopurinol (100 mg) Tablets 2. Chlorquinaldol 100 mg 3. Saccharomyces Boulardii (250 mg) Capsule 4. Drotaverine Injection 5. Fluconazole (150 mg) Capsule 6. Nadroparin Calcium (7600) Injection 7. Lopinavir (200 mg) + Ritonavir (50 mg) 8. Furazolidone (100 mg) 9. Povidone Iodine (100 mg/120 ml) Solution 10. Calcium Gluconate (94 mg/ml) Injection 11. Haloperidol 2mg/ml 12. Paracetamol 500 mg 13. Bisoprolol 5 mg 14. Medazepam 10 mg 15. Paracetamol 10 mg/ml Solution 16. Hydroxychloroquine (200 mg) Tablet 17. Epinephrine 1mg/ml

23 Oct 2020

Povidone Iodine (10%) Solution needed in Kuwait [ENA08503]

Triplet Pharma, a distributor based in Kuwait is looking for suppliers of Povidone Iodine (10%) Solution. The required quantity is 10,000 units of 250 ml bottle. Interested suppliers can contact them via their email: ashrafsalim@outlook.com.

10 Sep 2020

Various Finished Dose Formulations needed in the Philippines [ENA06936]

A large importer & distributor based in the Philippines is looking for suppliers of Various Finished Dose Formulations. 1. Povidone-iodine 200mg Vaginal suppositories with Aerosil 5mg, Polyethylene Glycol-400 100mg, Polyethylene Glycol-1500 100mg & Polyethylene Glycol-4000 695mg. The required quantity is 10,000 boxes of 10 ovules/box, 2 orders/ year 2. Neomycin (Neomycin sulfate) 75000 IU Nasal spay with Dexamethasone natri phosphate 15 mg & Xylometazolin HCl 7.5 mg. The required quantity is 40,000 units/ year.

25 Mar 2020

Tender//Supply of various pharmaceuticals products to SADC Member states [ENA04014] [Part 2/3]

Part[2/3] The Government of the United Republic of Tanzania has issued submission of a bid for tender number IE-009/2018/2019/HQ/G/101 closing on 21/05/2019. Estimated quantities are for two years: 21. Azithromycin Dehydrate 250 mg Capsule (630,122 units) 22. Ceftriaxone PDR F Injection 1 g (6,639,465 units) 23. Chlorpromazine 100 mg Tablet (341,536 units) 24. Diclofenac Sodium 25 mg/ml, 3 ml Ampoule (695,931 units) 25. Doxycycline 100 mg Capsule (1,175,190 units) 26. Fluconazole 150 mg Tablet (230,328 units) 27. Fluphenazine Decanoate 25 mg/ml Injection (199,385 units) 28. Folic Acid 10 mg Tablet (123,600 units) 29. Frusemide 2 ml Injection 10 mg/ml (734,362 units) 30. Frusemide 40 mg Tablet (842,200 units) 31. Haloperidol 1.5 mg Tablet (171,701 units) 32. Hepatitis B Vaccines Injection Single Dose (237,782 units) 33. Hydralazine 25mg Tablet (50,316 units) 34. Losartan 50 mg + Hydrochlorthiazide 12.5 mg (266,788 units) 35. Methyldopa 250 mg Tablet (568,350 units) 36. Nifedipine Retard 20 mg Tablet (1,981,457 units) 37. Phenobarbital 30 mg Tablet (1,123,699 units) 38. Phenobarbital Sodium 100 mg/ml Injection 2 ml (58,971 units) 39. Povidone Iodine Liquid 10% (1,430,308 units) 40. Sodium Chloride + Dextrose Injection Isotonic, 500 ml (141,696 units)

25 Apr 2019

Minims Povidone-Iodine 5% w/v Eye Drops, Solution needed in Canada [ENA03513]

A Pharmaceutical organization working with companies looking to enter the Canadian pharmaceutical market is interested to connect with suppliers of Minims Povidone-Iodine 5% w/v Eye Drops, Solution.

23 Feb 2019

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Povidone Iodine Manufacturers

A Povidone Iodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Povidone Iodine, including repackagers and relabelers. The FDA regulates Povidone Iodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Povidone Iodine 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 Povidone Iodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Povidone Iodine Suppliers

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

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

Povidone Iodine USDMF

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

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

click here to find a list of Povidone Iodine suppliers with USDMF on PharmaCompass.

Povidone Iodine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Povidone Iodine Drug Master File in Japan (Povidone Iodine JDMF) empowers Povidone Iodine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Povidone Iodine JDMF during the approval evaluation for pharmaceutical products. At the time of Povidone Iodine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Povidone Iodine suppliers with JDMF on PharmaCompass.

Povidone Iodine CEP

A Povidone Iodine CEP of the European Pharmacopoeia monograph is often referred to as a Povidone Iodine Certificate of Suitability (COS). The purpose of a Povidone Iodine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Povidone Iodine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Povidone Iodine to their clients by showing that a Povidone Iodine CEP has been issued for it. The manufacturer submits a Povidone Iodine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Povidone Iodine CEP holder for the record. Additionally, the data presented in the Povidone Iodine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Povidone Iodine DMF.

A Povidone Iodine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Povidone Iodine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Povidone Iodine suppliers with CEP (COS) on PharmaCompass.

Povidone Iodine WC

A Povidone Iodine written confirmation (Povidone Iodine WC) is an official document issued by a regulatory agency to a Povidone Iodine manufacturer, verifying that the manufacturing facility of a Povidone Iodine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Povidone Iodine APIs or Povidone Iodine finished pharmaceutical products to another nation, regulatory agencies frequently require a Povidone Iodine WC (written confirmation) as part of the regulatory process.

click here to find a list of Povidone Iodine suppliers with Written Confirmation (WC) on PharmaCompass.

Povidone Iodine NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Povidone Iodine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Povidone Iodine API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Povidone Iodine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Povidone Iodine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Povidone Iodine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Povidone Iodine suppliers with NDC on PharmaCompass.

Povidone Iodine GMP

Povidone Iodine 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 Povidone Iodine 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 Povidone Iodine GMP manufacturer or Povidone Iodine GMP API supplier for your needs.

Povidone Iodine CoA

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

Povidone Iodine CoA mostly includes findings from lab analyses of a specific batch. For each Povidone Iodine 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.

Povidone Iodine may be tested according to a variety of international standards, such as European Pharmacopoeia (Povidone Iodine EP), Povidone Iodine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Povidone Iodine 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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ACTIVE PHARMA INGREDIENTS

28 API Suppliers

12 USDMF

7 CEP/COS

4 JDMF

3 EU WC

9 NDC API

10 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

188 FDF Dossiers

7 FDA Orange Book

46 Europe

13 Canada

2 Australia

104 South Africa

16 Listed Dossiers

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41 Topical

29 Solubilizers

24 Thickeners and Stabilizers

23 Parenteral

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18 Fillers, Diluents & Binders

17 Coating Systems & Additives

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11 Co-Processed Excipients

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10 Lubricants & Glidants

10 Taste Masking

9 Surfactant & Foaming Agents

8 Emulsifying Agents

8 Granulation

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6 Chewable & Orodispersible Aids

3 API Stability Enhancers

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