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    Chemistry

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    Also known as: Trulance, Guanilib, 467426-54-6, 467426-54-6 (free base), Plecanatide [usan:inn], Unii-7ik8z952ok
    Molecular Formula
    C65H104N18O26S4
    Molecular Weight
    1681.9  g/mol
    InChI Key
    NSPHQWLKCGGCQR-DLJDZFDSSA-N
    Plecanatide
    Plecanatide is an agonist of intestinal guanylate cyclase type C (GC-C) which is almost structurally identical to human uroguanylin, with laxative and anti-nociceptive activities. Upon oral administration, plecanatide binds to and activates GC-C receptors located on endothelial cells on the luminal surface of the intestinal epithelium. This increases the concentration of intracellular cyclic guanosine monophosphate (cGMP). cGMP activates the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel and stimulates the secretion of chloride and bicarbonate into the intestinal lumen. This also promotes sodium excretion into the lumen and osmosis. The increased intestinal fluid secretion accelerates gastrointestinal transit of intestinal contents, improves bowel movement, softens stool, and relieves constipation. In addition, plecanatide exerts its anti-nociceptive effects by increasing the concentration of extracellular cGMP which inhibits the activity of pain-sensitive nerves, decreases muscle contractions and may relieve intestinal pain.
    1 2D Structure

    Plecanatide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[[(1R,4S,7S,10S,13S,16R,19S,22S,25R,32S,38R)-10-(2-amino-2-oxoethyl)-25-[[(2S)-4-carboxy-2-[[(2S)-3-carboxy-2-[[(2S)-2,4-diamino-4-oxobutanoyl]amino]propanoyl]amino]butanoyl]amino]-22-(2-carboxyethyl)-32-[(1R)-1-hydroxyethyl]-4-methyl-19-(2-methylpropyl)-3,6,9,12,15,18,21,24,30,33,36-undecaoxo-7,13-di(propan-2-yl)-27,28,40,41-tetrathia-2,5,8,11,14,17,20,23,31,34,37-undecazabicyclo[14.13.13]dotetracontane-38-carbonyl]amino]-4-methylpentanoic acid
    2.1.2 InChI
    InChI=1S/C65H104N18O26S4/c1-25(2)15-34-55(98)80-41-24-113-110-21-38(58(101)77-37(65(108)109)16-26(3)4)71-44(87)20-69-62(105)50(30(10)84)83-61(104)40(78-51(94)29(9)70-63(106)48(27(5)6)81-57(100)35(18-43(68)86)76-64(107)49(28(7)8)82-60(41)103)23-112-111-22-39(59(102)73-32(53(96)75-34)11-13-45(88)89)79-54(97)33(12-14-46(90)91)72-56(99)36(19-47(92)93)74-52(95)31(66)17-42(67)85/h25-41,48-50,84H,11-24,66H2,1-10H3,(H2,67,85)(H2,68,86)(H,69,105)(H,70,106)(H,71,87)(H,72,99)(H,73,102)(H,74,95)(H,75,96)(H,76,107)(H,77,101)(H,78,94)(H,79,97)(H,80,98)(H,81,100)(H,82,103)(H,83,104)(H,88,89)(H,90,91)(H,92,93)(H,108,109)/t29-,30+,31-,32-,33-,34-,35-,36-,37-,38-,39-,40-,41-,48-,49-,50-/m0/s1
    2.1.3 InChI Key
    NSPHQWLKCGGCQR-DLJDZFDSSA-N
    2.1.4 Canonical SMILES
    CC1C(=O)NC2CSSCC(C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)CNC(=O)C(NC2=O)C(C)O)C(=O)NC(CC(C)C)C(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N1)C(C)C)CC(=O)N)C(C)C)CC(C)C)CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(CC(=O)N)N
    2.1.5 Isomeric SMILES
    C[C@H]1C(=O)N[C@H]2CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@H](NC(=O)CNC(=O)[C@@H](NC2=O)[C@@H](C)O)C(=O)N[C@@H](CC(C)C)C(=O)O)C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)C(C)C)CC(=O)N)C(C)C)CC(C)C)CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CC(=O)N)N
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Sp-304

    2. Trulance

    2.2.2 Depositor-Supplied Synonyms

    1. Trulance

    2. Guanilib

    3. 467426-54-6

    4. 467426-54-6 (free Base)

    5. Plecanatide [usan:inn]

    6. Unii-7ik8z952ok

    7. Sp-304 (synergy)

    8. 7ik8z952ok

    9. Gtpl9069

    10. Chembl2103867

    11. Hsdb 8405

    12. Dtxsid60196933

    13. Glxc-26182

    14. Ex-a4131

    15. Db13170

    16. [3-glutamic Acid(d>e)]human Uroguanylin

    17. (3-glutamic Acid(d>e))human Uroguanylin (ugn)

    18. L-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l-cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-l-leucine Cyclic (4-->12),(7-->15)-bis(disulfide)

    19. L-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l-cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-l-leucine Cyclic (4adagger?2),(7adagger?5)-bis(disulfide)

    20. L-leucine, L-asparaginyl-l-alpha-aspartyl-l-alpha-glutamyl-l-cysteinyl-l-alpha-glutamyl-l-leucyl-l- Cysteinyl-l-valyl-l-asparaginyl-l-valyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-, Cyclic (4->12),(7->15)-bis(disulfide)

    2.3 Create Date
    2013-02-04
    3 Chemical and Physical Properties
    Molecular Weight 1681.9 g/mol
    Molecular Formula C65H104N18O26S4
    XLogP3-8.2
    Hydrogen Bond Donor Count23
    Hydrogen Bond Acceptor Count31
    Rotatable Bond Count28
    Exact Mass1680.6252002 g/mol
    Monoisotopic Mass1680.6252002 g/mol
    Topological Polar Surface Area819 Ų
    Heavy Atom Count113
    Formal Charge0
    Complexity3490
    Isotope Atom Count0
    Defined Atom Stereocenter Count16
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Guanylyl Cyclase C Agonists; Gastrointestinal Agents

    National Library of Medicine's Medical Subject Headings. Plecanatide. Online file (MeSH, 2018). Available from, as of March 7, 2018: https://meshb.nlm.nih.gov/search

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Plecanatide is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of March 7, 2018: https://clinicaltrials.gov/

    Trulance is indicated in adults for the treatment of: chronic idiopathic constipation (CIC); Irritable bowel syndrome with constipation (IBS-C). /Included in US product label/

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    /EXPL THER/ /The aim of this study was/ to evaluate the effect of orally administered plecanatide or dolcanatide, analogs of uroguanylin, on amelioration of colitis in murine models. The cyclic guanosine monophosphate (cGMP) stimulatory potency of plecanatide and dolcanatide was measured using a human colon carcinoma T84 cell-based assay. For animal studies all test agents were formulated in phosphate buffered saline. Sulfasalazine or 5-amino salicylic acid (5-ASA) served as positive controls. Effect of oral treatment with test agents on amelioration of acute colitis induced either by dextran sulfate sodium (DSS) in drinking water or by rectal instillation of trinitrobenzene sulfonic (TNBS) acid, was examined in BALB/c and/or BDF1 mice. Additionally, the effect of orally administered plecanatide on the spontaneous colitis in T-cell receptor alpha knockout (TCRa(-/-)) mice was also examined. Amelioration of colitis was assessed by monitoring severity of colitis, disease activity index and by histopathology. Frozen colon tissues were used to measure myeloperoxidase activity. Plecanatide and dolcanatide are structurally related analogs of uroguanylin, which is an endogenous ligand of guanylate cyclase-C (GC-C). As expected from the agonists of GC-C, both plecanatide and dolcanatide exhibited potent cGMP-stimulatory activity in T84 cells. Once-daily treatment by oral gavage with either of these analogs (0.05-0.5 mg/kg) ameliorated colitis in both DSS and TNBS-induced models of acute colitis, as assessed by body weight, reduction in colitis severity (P < 0.05) and disease activity index (P < 0.05). Amelioration of colitis by either of the drug candidates was comparable to that achieved by orally administered sulfasalazine or 5-ASA. Plecanatide also effectively ameliorated colitis in TCRa(-/-) mice, a model of spontaneous colitis. As dolcanatide exhibited higher resistance to proteolysis in simulated gastric and intestinal juices, it was selected for further studies. This is the first-ever study reporting the therapeutic utility of GC-C agonists as a new class of orally delivered and mucosally active drug candidates for the treatment of inflammatory bowel diseases.

    PMID:26558155 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4635161 Shailubhai K et al; World J Gastrointest Pharmacol Ther 6 (4): 213-22 (2015)

    4.2 Drug Warning

    /BOXED WARNING/ WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS. Trulance is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Avoid use of Trulance in patients 6 years to less than 18 years of age. The safety and effectiveness of Trulance have not been established in patients less than 18 years of age.

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    Since systemic absorption of plecanatide and its active metabolite is negligible following oral administration, the drug is not expected to result in fetal exposure if administered to pregnant women. However, available data on use of plecanatide in pregnant women are insufficient to inform fetal risk.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    It is not known whether plecanatide is distributed into human milk, affects milk production, or affects the breast-fed infant. Systemic absorption of plecanatide and its active metabolite is negligible following oral administration. It is not known whether the negligible systemic absorption observed in adults will result in clinically important exposure in breast-fed infants. The benefits of breast-feeding and the importance of plecanatide to the woman should be considered along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. Exposure of infants to plecanatide could result in serious adverse effects.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    Trulance is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration. Patients with known or suspected mechanical gastrointestinal obstruction.

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    For more Drug Warnings (Complete) data for Plecanatide (10 total), please visit the HSDB record page.

    4.3 Drug Indication

    Plecanatide stimulates intestinal fluid secretions in the gastrointestinal tract to support regular bowel function. Plecanatide, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Food Effect Subjects who received either a low-fat, low calorie (LF-LC) meal or a high fat, high calorie (HF-HC) meal reported looser stools than fasted subjects up to 24 hours after a single dose of 9 mg (3 times the recommended dose). In clinical studies, Plecanatide was administered with or without food.

    5.2 MeSH Pharmacological Classification

    Gastrointestinal Agents

    Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)

    Guanylyl Cyclase C Agonists

    Compunds that bind to and activate GUANYLYL CYCLASE-C RECEPTORS. (See all compounds classified as Guanylyl Cyclase C Agonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Guanylate Cyclase-C Agonist [EPC]; Guanylate Cyclase Activators [MoA]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A06 - Drugs for constipation

    A06A - Drugs for constipation

    A06AX - Other drugs for constipation

    A06AX07 - Plecanatide

    5.5 Absorption, Distribution and Excretion

    Absorption

    Plecanatide is minimally absorbed with negligible systemic availability following oral administration. Concentrations of plecanatide and its active metabolite in plasma are below the limit of quantitation after an oral dose of 3 mg. Therefore, standard pharmacokinetic parameters such as AUC, maximum concentration (Cmax), and half-life (t) cannot be calculated.

    Route of Elimination

    No excretion studies have been conducted in humans. Plecanatide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses.

    Volume of Distribution

    Concentrations of plecanatide and its active metabolite in plasma are below the limit of quantitation after an oral dose of 3 mg. Therefore, the volume of distribution can not be calculated.

    Clearance

    No excretion studies have been conducted in humans.

    Given that plecanatide concentrations following clinically relevant oral doses were not measurable, plecanatide is expected to be minimally distributed in tissues. Oral plecanatide was localized to the GI tract where it exerted its effects as a guanylate cyclase-C (GC-C) agonist with negligible systemic exposure. Plecanatide exhibited little to no binding to human serum albumin or human a-1-acid glycoprotein.

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    In a crossover study, 24 healthy subjects were given a single dose of Trulance 9 mg (3 times the recommended dose) in 3 different states: fasted; following a low-fat, low-calorie meal (LF-LC; approximately 350 calories: 17% from fat, 66% from carbohydrate, and 17% from protein); and following a high-fat, high-calorie meal (HF-HC; approximately 1000 calories: 60% from fat, 25% from carbohydrate, and 15% from protein). Plecanatide was detected in 1 subject (fasted state) at 0.5 and 1 hour post dose. Plecanatide concentrations were below the limit of quantitation for all other time points and for all other subjects. The active metabolite was not detected in any subject.

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    Plecanatide was minimally absorbed with negligible systemic availability following oral administration. Concentrations of plecanatide and its active metabolite in plasma were below the limit of quantitation in the majority of analyzed plasma samples after an oral Trulance dose of 3 mg. Therefore, standard pharmacokinetic parameters such as AUC, maximum concentration (Cmax), and half-life could not be calculated.

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    5.6 Metabolism/Metabolites

    Plecanatide is metabolized in the GI tract to an active metabolite by loss of the terminal leucine moiety. Both plecanatide and the metabolite are proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids.

    Plecanatide was metabolized in the GI tract to an active metabolite by loss of the terminal leucine moiety. Both plecanatide and the metabolite were proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids.

    NIH; DailyMed. Current Medication Information for Trulance Immediate Release (Plecanatide) Tablet (Updated: February 7, 2018). Available from, as of March 21, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1766455-79a2-409f-9325-0e3d6743acc7

    5.7 Biological Half-Life

    half-life (t) cannot be calculated due to negligible systemic absorbance

    5.8 Mechanism of Action

    Guanylate cyclase C (GC-C) agonist Plecanatide and its active metabolite bind to GC-C and act locally on the luminal surface of intestinal epithelial cells; GC-C activation leads to increased cyclic guanosine monophosphate (cGMP), which, in turn, stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly by activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. In animal models, plecanatide has been shown to increase fluid secretion into the gastrointestinal (GI) tract, accelerate intestinal transit, and cause changes in stool consistency. In an animal model of visceral pain, plecanatide reduced abdominal muscle contractions, a measure of intestinal pain. The mechanism has not been studied.

    Plecanatide, a guanylate cyclase-C (GC-C) agonist, is a 16-amino acid peptide structurally related to endogenous uroguanylin peptide hormone. The parent drug and its active metabolite bind to GC-C receptors on the luminal surface of the intestinal epithelium, which increases intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). In turn, increased intracellular concentrations of cGMP trigger a signal-transduction cascade activating the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel. This results in secretion of chloride and bicarbonate into the intestinal lumen causing increased intestinal fluid and accelerated intestinal transit.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    Plecanatide is a recently developed guanylate cyclase-C (GC-C) agonist and the first uroguanylin analog designed to treat chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). GC-C receptors are found across the length of the intestines and are thought to play a key role in fluid regulation and electrolyte balance. Ligands of the GC-C receptor include endogenous agonists, uroguanylin and guanylin, as well as diarrheagenic, Escherichia coli heat-stable enterotoxins (ST). Plecanatide mimics uroguanylin in its 2 disulfide-bond structure and in its ability to activate GC-Cs in a pH-dependent manner, a feature associated with the presence of acid-sensing residues (Asp2 and Glu3). Linaclotide, a synthetic analog of STh (a 19 amino acid member of ST family), contains the enterotoxin's key structural elements, including the presence of three disulfide bonds. Linaclotide, like STh, activates GC-Cs in a pH-independent manner due to the absence of pH-sensing residues. In this study, molecular dynamics simulations compared the stability of plecanatide and linaclotide to STh. Three-dimensional structures of plecanatide at various protonation states (pH 2.0, 5.0, and 7.0) were simulated with GROMACS software. Deviations from ideal binding conformations were quantified using root mean square deviation values. Simulations of linaclotide revealed a rigid conformer most similar to STh. Plecanatide simulations retained the flexible, pH-dependent structure of uroguanylin. The most active conformers of plecanatide were found at pH 5.0, which is the pH found in the proximal small intestine. GC-C receptor activation in this region would stimulate intraluminal fluid secretion, potentially relieving symptoms associated with CIC and IBS-C.

    PMID:28357122 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5368960 Brancale A et al; Pharmacol Res Perspect 5 (2): e00295 (2017)

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    ABOUT THIS PAGE

    Plecanatide Manufacturers

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

    Plecanatide Suppliers

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

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

    Plecanatide USDMF

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

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

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

    Plecanatide 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 Plecanatide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Plecanatide 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 Plecanatide 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 Plecanatide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Plecanatide NDC to their finished compounded human drug products, they may choose to do so.

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

    Plecanatide GMP

    Plecanatide 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 Plecanatide 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 Plecanatide GMP manufacturer or Plecanatide GMP API supplier for your needs.

    Plecanatide CoA

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

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

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