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    Also known as: Dexnorgestrel acetime, 35189-28-7, Anti-norgestimate, Norgestimate, e-, Norgestimato, Norgestimatum
    Molecular Formula
    C23H31NO3
    Molecular Weight
    369.5  g/mol
    InChI Key
    KIQQMECNKUGGKA-NMYWJIRASA-N
    FDA UNII
    NKX8DN6TY9
    Norgestimate
    Norgestimate was first described in the literature in 1977. It was developed by Ortho Pharmaceutical Corporation as part of an effort to develop new hormonal contraceptives with reduced adverse effects. It is commonly formulated with [ethinylestradiol] as a combined oral contraceptive that can also be used to treat moderate acne vulgaris. Norgestimate was granted FDA approval on 29 December 1989.
    1 2D Structure

    Norgestimate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(3E,8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate
    2.1.2 InChI
    InChI=1S/C23H31NO3/c1-4-22-12-10-19-18-9-7-17(24-26)14-16(18)6-8-20(19)21(22)11-13-23(22,5-2)27-15(3)25/h2,14,18-21,26H,4,6-13H2,1,3H3/b24-17+/t18-,19+,20+,21-,22-,23-/m0/s1
    2.1.3 InChI Key
    KIQQMECNKUGGKA-NMYWJIRASA-N
    2.1.4 Canonical SMILES
    CCC12CCC3C(C1CCC2(C#C)OC(=O)C)CCC4=CC(=NO)CCC34
    2.1.5 Isomeric SMILES
    CC[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@]2(C#C)OC(=O)C)CCC4=C/C(=N/O)/CC[C@H]34
    2.2 Other Identifiers
    2.2.1 UNII
    NKX8DN6TY9
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Norgestrel Oxime Acetate

    2.3.2 Depositor-Supplied Synonyms

    1. Dexnorgestrel Acetime

    2. 35189-28-7

    3. Anti-norgestimate

    4. Norgestimate, E-

    5. Norgestimato

    6. Norgestimatum

    7. Norgestimatum [inn-latin]

    8. Norgestimato [inn-spanish]

    9. Orf-10131

    10. Nkx8dn6ty9

    11. [(3e,8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] Acetate

    12. (+)-13-ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one Oxime Acetate (ester)

    13. 20799-27-3

    14. Chebi:50815

    15. Orf 10131

    16. Rwj 10131

    17. Ncgc00181353-01

    18. (17alpha)-17-(acetyloxy)-13-ethyl-18,19-dinorpregn-4-en-20-yn-3-one 3-oxime

    19. Dsstox_cid_26922

    20. Dsstox_rid_82018

    21. Dsstox_gsid_46922

    22. 107382-52-5

    23. D-13beta-ethyl-17alpha-ethynyl-17beta-acetoxygon-4-en-3-one Oxime

    24. Rwj-10131

    25. Cas-35189-28-7

    26. Norgestimate (usp/inn)

    27. Nsc-759159

    28. Unii-nkx8dn6ty9

    29. Schembl38317

    30. Schembl38318

    31. Chembl1200934

    32. Dtxsid1046922

    33. Norgestimate, >=97% (hplc)

    34. Norgestimate For System Suitability

    35. Tox21_112811

    36. Ac-655

    37. (3e)-17alpha-ethynyl-3-(hydroxyimino)-18a-homoestr-4-en-17beta-yl Acetate

    38. Akos015917555

    39. Tox21_112811_1

    40. Db00957

    41. Ncgc00344561-01

    42. As-12305

    43. D05209

    44. 351n287

    45. A822635

    46. J-019983

    47. 18,19-dinorpregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, 3-oxime, (3e,17alpha)-

    48. (1s,2r,5e,10r,11s,14r,15s)-15-ethyl-14-ethynyl-5-(hydroxyimino)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl Acetate

    49. [(3e,8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] Acetate;norgestimate

    50. 18,19-dinorpregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-, 3-oxime, (3e,17.alpha.)-

    2.4 Create Date
    2006-05-23
    3 Chemical and Physical Properties
    Molecular Weight 369.5 g/mol
    Molecular Formula C23H31NO3
    XLogP34.1
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count4
    Exact Mass369.23039385 g/mol
    Monoisotopic Mass369.23039385 g/mol
    Topological Polar Surface Area58.9 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity744
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Contraceptives, Oral, Synthetic; Norgestrel/analogs & derivatives

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

    Norgestimate/ethinyl estradiol is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    4.2 Drug Warning

    /BOXED WARNING/ WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including MonoNessa, should not be used by women who are over 35 years of age and smoke.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (Updated: February 2015). Available from, as of April 23, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=704ba4ae-edd0-4298-a399-03a49f8411c7

    Oral contraceptives should not be used in women who currently have the following conditions: thrombophlebitis or thromboembolic disorders; a past history of deep vein thrombophlebitis or thromboembolic disorders; cerebral vascular or coronary artery disease (current or past history); valvular heart disease with complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; acute or chronic hepatocellular disease with abnormal liver function; hepatic adenomas or carcinomas; known or suspected pregnancy; hypersensitivity to any component of this product.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, and smoking interacted to increase the risk of stroke. In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension. The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    For more Drug Warnings (Complete) data for Norgestimate (44 total), please visit the HSDB record page.

    4.3 Drug Indication

    Norgestimate is formulated with [ethinylestradiol] as a combined oral contraceptive. It can also be given with low dose ethinylestradiol for contraception as well as the treatment of moderate acne vulgaris in women 15 years old.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Norgestimate is a progestin that suppresses ovulation for contraception and reduces free testosterone to treat moderate acne vulgaris. The therapeutic index is wide as overdoses are rare. Patients should be counselled regarding the risk of vascular problems, liver disease, hypertension, metabolic effects, headaches, and bleeding irregularities.

    5.2 MeSH Pharmacological Classification

    Contraceptives, Oral, Synthetic

    Oral contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Oral, Synthetic.)

    Contraceptive Agents, Hormonal

    Contraceptive agents that act on the ENDOCRINE SYSTEM. (See all compounds classified as Contraceptive Agents, Hormonal.)

    5.3 Absorption, Distribution and Excretion

    Absorption

    Oral norgestimate has a Tmax of 0.5-2h. On day 21 of cycle 3, 17-desacetylnorgestimate reaches a Cmax of 1.82ng/mL, with a Tmax of 1.5h, and an AUC of 16.1h\*ng/mL. At the same time, norgestrel reaches a Cmax of 2.79ng/mL, with a Tmax of 1.7h, and an AUC of 49.9h\*ng/mL.

    Route of Elimination

    Norgestimate is 45-49% eliminated in urine and 16-49% eliminated in feces. Unchanged norgestimate is not detected in urine.

    Volume of Distribution

    Data regarding the volume of distribution of norgestimate are not readily available.

    Clearance

    Data regarding the clearance of norgestimate is not readily available.

    Norgestimate (NGM) and ethinyl estradiol (EE) are rapidly absorbed following oral administration.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    Peak serum concentrations of norelgestromin (NGMN) and ethinyl estradiol (EE) are generally reached by 2 hours after administration of MonoNessa. Accumulation following multiple dosing of the 250 ug Norgestimate (NGM)/ 35 ug dose is approximately 2-fold for NGMN and EE compared with single dose administration. The pharmacokinetics of NGMN is dose proportional following NGM doses of 180 ug to 250 ug. ... Steady-state concentrations of NGMN and NG are achieved by Day 21. Non-linear accumulation (approximately 8 fold) of norgestrel is observed as a result of high affinity binding to SHBG (sex hormone-binding globulin), which limits its biological activity.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    Norelgestromin and norgestrel are highly bound (>97%) to serum proteins. Norelgestromin is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways. Following administration of 14C-norgestimate, 47% (45-49%) and 37% (16-49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Unchanged norgestimate was not detected in the urine.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    5.4 Metabolism/Metabolites

    Norgestimate is rapidly deacetylated to the active 17-desacetylnorgestimate, which is deoximated to the active norgestrel. 17-desacetylnorgestimate is metabolized to a number of undefined hydroxylated metabolites, mainly by CYP3A4 and to a lesser extend by CYP2B6 and CYP2C9. Norgestrel is O-glucuronidated by UGT1A1 or oxidized to a number of undefined hydroxylated metabolites by CYP3A4.

    Norgestimate is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    Norgestimate is extensively metabolized by first-pass mechanisms in the gastrointestinal tract and/or liver. Norgestimate's primary active metabolite is norelgestromin. Subsequent hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is also active, and various hydroxylated and conjugated metabolites.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    In addition to 17-deacetyl norgestimate, a number of metabolites of norgestimate have been identified in human urine following administration of radiolabeled norgestimate. These include 18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17alpha)-(-); 18,19-Dinor-5beta-17-pregnan-20-yn,3alpha,17beta-dihydroxy-13-ethyl,(17alpha), various hydroxylated metabolites and conjugates of these metabolites.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    There is limited information on the metabolism of levonorgestrel, norethindrone and structurally related contraceptive steroids. Both levonorgestrel and norethindrone undergo extensive reduction of the alpha, beta-unsaturated ketone in ring A. Levonorgestrel also undergoes hydroxylation at carbons 2 and 16. The metabolites of both compounds circulate predominantly as sulfates. In urine, levonorgestrel metabolites are found primarily in the glucuronide form, whereas norethindrone metabolites are present in approximately equal amounts as sulfates and glucuronides. Of the progestogens structurally related to norethindrone, norethindrone acetate, ethynodiol diacetate, norethindrone enanthate, and perhaps lynestrenol, undergo rapid hydrolysis and are converted to the parent compound and its metabolites. There is no convincing evidence that norethynodrel is converted to norethindrone. Of the progestogens structurally related to levonorgestrel, it appears that neither desogestrel nor gestodene are transformed to the parent compound. However, there is evidence that norgestimate can be, at least partly, converted to levonorgestrel. ...

    PMID:2143719 Stanczyk FZ, Roy S; Contraception 42 (1): 67-96 (1990)

    5.5 Biological Half-Life

    Norgestimate is rapidly deacetylated. The active metabolites of norgestimate, 17-desacetyl norgestimate, has a half life of 12-30h, while norgestrel has a half life of 36.410.2h.

    5.6 Mechanism of Action

    Progesterone analogs like norgestimate decrease the frequency of gonadotropin releasing hormone pulses from the hypothalamus, decreasing follicle stimulating hormone and luteinizing hormone. These actions prevent ovulation. Norgestimate suppresses the hypothalamo-pituitary-axis, reducing androgen synthesis. It also induces production of sex hormone binding globulin, which decreases free testosterone. These actions together result in less testosterone being available to stimulate sebaceous glands, resulting in effective treatment of some forms of acne.

    Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate, the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity. Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin (SHBG), resulting in lower serum testosterone.

    US Natl Inst Health; DailyMed. Current Medication Information for MONONESSA (norgestimate and ethinyl estradiol) kit (December 2010). Available from, as of March 30, 2011: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=33976

    Progestins enter target cells by passive diffusion and bind to cytosolic (soluble) receptors that are loosely bound in the nucleus. The steroid receptor complex initiates transcription, resulting in an increase in protein synthesis. /Progestins/

    USP. Convention. USPDI - Drug Information for the Health Care Professional. 20th ed. Volume I. Micromedex, Inc. Englewood, CO., 2000. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2568

    Progestins are capable of affecting serum concentrations of other hormones, particularly estrogen. Estrogenic effects are modified by the progestins, either by reducing the availability or stability of the hormone receptor complex or by turning off specific hormone-responsive genes by direct interaction with the progestin receptor in the nucleus. In addition, estrogen priming is necessary to increase progestin effects by upregulating the number of progestin receptors and/or increasing progesterone production, causing a negative feedback mechanism that inhibits estrogen receptors. /Progestins/

    USP. Convention. USPDI - Drug Information for the Health Care Professional. 20th ed. Volume I. Micromedex, Inc. Englewood, CO., 2000. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2568

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    23-May-2022
    01-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Fe...DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19653

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    DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19697

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    DOSAGE - TABLET;ORAL-28 - 0.025MG,0.025MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21241

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    ABOUT THIS PAGE

    Looking for 35189-28-7 / Norgestimate API manufacturers, exporters & distributors?

    Norgestimate manufacturers, exporters & distributors 1

    41

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norgestimate manufacturer or Norgestimate supplier.

    PharmaCompass also assists you with knowing the Norgestimate API Price utilized in the formulation of products. Norgestimate API Price is not always fixed or binding as the Norgestimate Price is obtained through a variety of data sources. The Norgestimate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Norgestimate

    Synonyms

    Dexnorgestrel acetime, 35189-28-7, Anti-norgestimate, Norgestimate, e-, Norgestimato, Norgestimatum

    Cas Number

    35189-28-7

    Unique Ingredient Identifier (UNII)

    NKX8DN6TY9

    About Norgestimate

    Norgestimate was first described in the literature in 1977. It was developed by Ortho Pharmaceutical Corporation as part of an effort to develop new hormonal contraceptives with reduced adverse effects. It is commonly formulated with [ethinylestradiol] as a combined oral contraceptive that can also be used to treat moderate acne vulgaris. Norgestimate was granted FDA approval on 29 December 1989.

    PREFEST-1 Manufacturers

    A PREFEST-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREFEST-1, including repackagers and relabelers. The FDA regulates PREFEST-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREFEST-1 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 PREFEST-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    PREFEST-1 Suppliers

    A PREFEST-1 supplier is an individual or a company that provides PREFEST-1 active pharmaceutical ingredient (API) or PREFEST-1 finished formulations upon request. The PREFEST-1 suppliers may include PREFEST-1 API manufacturers, exporters, distributors and traders.

    click here to find a list of PREFEST-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    PREFEST-1 USDMF

    A PREFEST-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of PREFEST-1 active pharmaceutical ingredient (API) in detail. Different forms of PREFEST-1 DMFs exist exist since differing nations have different regulations, such as PREFEST-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A PREFEST-1 DMF submitted to regulatory agencies in the US is known as a USDMF. PREFEST-1 USDMF includes data on PREFEST-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PREFEST-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of PREFEST-1 suppliers with USDMF on PharmaCompass.

    PREFEST-1 CEP

    A PREFEST-1 CEP of the European Pharmacopoeia monograph is often referred to as a PREFEST-1 Certificate of Suitability (COS). The purpose of a PREFEST-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PREFEST-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PREFEST-1 to their clients by showing that a PREFEST-1 CEP has been issued for it. The manufacturer submits a PREFEST-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PREFEST-1 CEP holder for the record. Additionally, the data presented in the PREFEST-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PREFEST-1 DMF.

    A PREFEST-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PREFEST-1 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 PREFEST-1 suppliers with CEP (COS) on PharmaCompass.

    PREFEST-1 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 PREFEST-1 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for PREFEST-1 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 PREFEST-1 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 PREFEST-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PREFEST-1 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of PREFEST-1 suppliers with NDC on PharmaCompass.

    PREFEST-1 GMP

    PREFEST-1 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 PREFEST-1 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 PREFEST-1 GMP manufacturer or PREFEST-1 GMP API supplier for your needs.

    PREFEST-1 CoA

    A PREFEST-1 CoA (Certificate of Analysis) is a formal document that attests to PREFEST-1's compliance with PREFEST-1 specifications and serves as a tool for batch-level quality control.

    PREFEST-1 CoA mostly includes findings from lab analyses of a specific batch. For each PREFEST-1 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.

    PREFEST-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (PREFEST-1 EP), PREFEST-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PREFEST-1 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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