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    Also known as: 5949-44-0, Andriol, Testosterone undecylate, Nebido, Testosterone (undecanoate), Aveed
    Molecular Formula
    C30H48O3
    Molecular Weight
    456.7  g/mol
    InChI Key
    UDSFVOAUHKGBEK-CNQKSJKFSA-N
    FDA UNII
    H16A5VCT9C
    Testosterone Undecanoate
    Testosterone Undecanoate is the undecanoate ester form of the androgen testosterone, with gonadotropin-secretory inhibiting and hormone replacement activity. As testosterone inhibits the secretion of gonadotropins from the pituitary gland, administration of testosterone decreases the secretion of luteinizing hormone (LH). By inhibiting LH secretion, the growth of Leydig cells, which are normally stimulated by LH to produce testosterone, may be suppressed. In addition, this agent promotes the maintenance of male sex characteristics and can be used for testosterone replacement in hypogonadal males.
    1 2D Structure

    Testosterone Undecanoate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(8R,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] undecanoate
    2.1.2 InChI
    InChI=1S/C30H48O3/c1-4-5-6-7-8-9-10-11-12-28(32)33-27-16-15-25-24-14-13-22-21-23(31)17-19-29(22,2)26(24)18-20-30(25,27)3/h21,24-27H,4-20H2,1-3H3/t24-,25-,26-,27-,29-,30-/m0/s1
    2.1.3 InChI Key
    UDSFVOAUHKGBEK-CNQKSJKFSA-N
    2.1.4 Canonical SMILES
    CCCCCCCCCCC(=O)OC1CCC2C1(CCC3C2CCC4=CC(=O)CCC34C)C
    2.1.5 Isomeric SMILES
    CCCCCCCCCCC(=O)O[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C
    2.2 Other Identifiers
    2.2.1 UNII
    H16A5VCT9C
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Andriol

    2. Nebido

    3. Pantestone

    4. Restandol

    5. Testosterone Undecylate

    6. Undestor

    2.3.2 Depositor-Supplied Synonyms

    1. 5949-44-0

    2. Andriol

    3. Testosterone Undecylate

    4. Nebido

    5. Testosterone (undecanoate)

    6. Aveed

    7. Org 538

    8. Testosterone Undeconate

    9. Jatenzo

    10. Testosterone Undecanoate [usan]

    11. Testosterone, Undecanoate (ester)

    12. Undestor

    13. H16a5vct9c

    14. Org-538

    15. Testosterone 17.beta.-undecylate

    16. Tsx-011

    17. [(8r,9s,10r,13s,14s,17s)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] Undecanoate

    18. Mk-3033

    19. Androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17b)-

    20. Pantestone

    21. Restandol

    22. T Undecanoate

    23. Testosterone Undecanoate (usan)

    24. Rextoro

    25. Nebido-r

    26. Reandron 1000

    27. Einecs 227-712-6

    28. Unii-h16a5vct9c

    29. Brn 3176734

    30. 17beta-hydroxyandrost-4-en-3-one Undecanoate

    31. Andriol (tn)

    32. Aveed (tn)

    33. 5-alpha-androstan-3-one, 17-beta-hydroxy-, Undecanoate

    34. Bay 86-5037

    35. 3-oxoandrost-4-en-17beta-yl Undecanoate

    36. Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)-

    37. Testosterone, Undecanoate

    38. 4-08-00-00981 (beilstein Handbook Reference)

    39. Schembl147620

    40. Chembl2107067

    41. Clr-610

    42. Dtxsid90863661

    43. Chebi:135741

    44. Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17beta)-

    45. (8r,9s,10r,13s,14s,17s)-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl Undecanoate

    46. Bcp11921

    47. Hy-b0626

    48. Zinc8214690

    49. Mfcd00468114

    50. Testosterone Undecanoate [mi]

    51. Akos016010255

    52. Cs-4342

    53. Db13946

    54. Gs-6598

    55. Testosterone Undecylate [mart.]

    56. 17beta-undecanoyloxy-4-androsten-3-one

    57. Testosterone Undecanoate [vandf]

    58. Ncgc00484056-01

    59. Testosterone Undecanoate [who-dd]

    60. Testosterone Undecanoate [orange Book]

    61. D06087

    62. (17beta)-3-oxoandrost-4-en-17-yl Undecanoate

    63. (17-beta)-3-oxoandrost-4-en-17-yl Undecanoate

    64. 949t440

    65. 3-oxoandrost-4-en-17.beta.-yl Undecanoate

    66. W-105318

    67. Q15410178

    68. 17.beta.-hydroxyandrost-4-en-3-one Undecanoate

    69. (17.beta.)-17-hydroxyandrost-4-en-3-one Undecanoate

    70. 5-.alpha.-androstan-3-one, 17-.beta.-hydroxy-, Undecanoate

    71. Androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17.beta.)-

    72. .delta.(sup 4)-androsten-17.beta.-ol-3-one Undecanoate

    73. Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-(17.beta.)

    74. (1s,2r,10r,11s,14s,15s)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-14-yl Undecanoate

    75. (1s,2r,10r,11s,14s,15s)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl Undecanoate

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 456.7 g/mol
    Molecular Formula C30H48O3
    XLogP38.5
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count11
    Exact Mass456.36034539 g/mol
    Monoisotopic Mass456.36034539 g/mol
    Topological Polar Surface Area43.4 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity739
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameAveed
    PubMed HealthTestosterone (Injection)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelAveed (testosterone undecanoate) injection contains testosterone undecanoate (17-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoat...
    Active IngredientTestosterone undecanoate
    Dosage FormInjectable
    RouteIntramuscular
    Strength750mg/3ml (250mg/ml)
    Market StatusPrescription
    CompanyEndo Pharms

    2 of 2  
    Drug NameAveed
    PubMed HealthTestosterone (Injection)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelAveed (testosterone undecanoate) injection contains testosterone undecanoate (17-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoat...
    Active IngredientTestosterone undecanoate
    Dosage FormInjectable
    RouteIntramuscular
    Strength750mg/3ml (250mg/ml)
    Market StatusPrescription
    CompanyEndo Pharms

    4.2 Drug Indication

    Testosterone undecanoate is indicated for replacement therapy in adult males with conditions that are linked with an absence or deficiency in endogenous testosterone production.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Testosterone plays a key role in male sexual differentiation and is involved in regulation of hematopoiesis, body composition, and bone metabolism. As a result, testosterone replacement therapy in males with hypogonadism can result in improved sexual function, increased lean body mass, bone density, erythropoiesis, prostate size, and changes in lipid profiles.

    5.2 MeSH Pharmacological Classification

    Androgens

    Compounds that interact with ANDROGEN RECEPTORS in target tissues to bring about the effects similar to those of TESTOSTERONE. Depending on the target tissues, androgenic effects can be on SEX DIFFERENTIATION; male reproductive organs, SPERMATOGENESIS; secondary male SEX CHARACTERISTICS; LIBIDO; development of muscle mass, strength, and power. (See all compounds classified as Androgens.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Androgen [EPC]; Androstanes [CS]; Androgen Receptor Agonists [MoA]
    5.4 Absorption, Distribution and Excretion

    Absorption

    The absorption of testosterone undecanoate varies based on the formulation. The intramuscular formulation of testosterone esters is suspended in oil and is absorbed from the lipid phase. Testosterone is released when tissue esterases cleave the undecanoic acid side chain. The oral formulation of testosterone undecanoate is also formulated as a prodrug, is best absorbed with food and ideal absorption occurs when taken with a meal containing at least 30 g of fat.

    Route of Elimination

    The majority (~90%) of an intramuscularly administered dose of testosterone is conjugated and eliminated in the urine. Approximately 6% of the dose is eliminated primarily unconjugated in the feces.

    5.5 Metabolism/Metabolites

    The side chain of testosterone undecanoate is cleaved by non specific esterases when it enters circulation and the undecanoic acid side chain is metabolized by the beta-oxidation pathway. The resulting Testosterone molecule is then metabolized to dihydrotestosterone (DHT) by the enzyme 5-alpha reductase. DHT is reduced by 3-alpha-hydroxysteroid dehydrogenase (major) and 3-beta-hydroxysteroid dehydrogenase prior to being glucuronidated and cleared by the kidneys. It should be noted that testosterone is metabolized to several other 17-keto steroids in the body.

    5.6 Biological Half-Life

    Based on one source, Testosterone undecanoate in castor oil (for intramuscular injection) has a half life of 33.9 days, allowing it to maintain serum levels in the normal range for over 6 weeks. It should be noted that the half life of testosterone reported in the literature is inconsistent.

    5.7 Mechanism of Action

    Testosterone is produced by Leydig cells and exerts it's effects by binding to androgen receptors throughout the body. Testosterone affects the voice, genitalia, mood, and influences muscle growth and protein expression. Accordingly, males with low levels of testosterone often experience decreased libido, fatigue, mood changes and dysphoria. Exogenous sources of testosterone are designed to mimic the effects of endogenous testosterone.

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INC","customerCountry":"BRAZIL","quantity":"57.00","actualQuantity":"57","unit":"KGS","unitRateFc":"1198.1","totalValueFC":"67120.8","currency":"USD","unitRateINR":93695,"date":"17-Aug-2022","totalValueINR":"5340615","totalValueInUsd":"67120.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4011781","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663957800,"product":"TESTOSTERONE UNDECANOATE","address":"114 MARINE CHAMBERS ,,11 NEW MARIN E LINES ,MUMBAI,","city":"MAHARASHTRA,MAHARASHTRA","supplier":"SWATI SPENTOSE","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"TO ORDER.","customerCountry":"INDONESIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"1.2","totalValueFC":"574","currency":"USD","unitRateINR":92,"date":"24-Sep-2022","totalValueINR":"46000","totalValueInUsd":"574","indian_port":"BOMBAY AIR","hs_no":"29372900","bill_no":"4406825","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"114 MARINE CHAMBERS ,,11 NEW MARIN E LINES ,MUMBAI,, MAHARASHTRA,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670524200,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ASHFORD INVEST & TRADE 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INC","customerCountry":"BRAZIL","quantity":"148.00","actualQuantity":"148","unit":"KGS","unitRateFc":"1215.1","totalValueFC":"179171.8","currency":"USD","unitRateINR":99573.945945945947,"date":"20-Mar-2023","totalValueINR":"14736944","totalValueInUsd":"179171.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4003927","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680460200,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"RENATA LIMITED","customerCountry":"BANGLADESH","quantity":"4.00","actualQuantity":"4","unit":"KGA","unitRateFc":"2162.5","totalValueFC":"8649.6","currency":"USD","unitRateINR":177217,"date":"03-Apr-2023","totalValueINR":"708868","totalValueInUsd":"8649.6","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4004869","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683657000,"product":"PHARMACEUTICAL RAW MATERIAL BULK DRUGS TESTOSTERONE UNDECANOATE","address":"114 MARINE CHAMBERS ,,11 NEW MARIN E LINES ,MUMBAI,","city":"MAHARASHTRA,MAHARASHTRA","supplier":"SWATI SPENTOSE","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"TO THE ORDER","customerCountry":"VIETNAM","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"850","totalValueFC":"826.4","currency":"USD","unitRateINR":68000,"date":"10-May-2023","totalValueINR":"68000","totalValueInUsd":"826.4","indian_port":"BOMBAY AIR","hs_no":"29372900","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"114 MARINE CHAMBERS ,,11 NEW MARIN E LINES ,MUMBAI,, MAHARASHTRA,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686508200,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"XXSH XXRFOXXANCXXMATXXIALXX(THXXLANXX LTXX","customerCountry":"THAILAND","quantity":"68.00","actualQuantity":"68","unit":"KGS","unitRateFc":"1075.5","totalValueFC":"72693.4","currency":"USD","unitRateINR":87869.558823529413,"date":"12-Jun-2023","totalValueINR":"5975130","totalValueInUsd":"72693.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4008621","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686681000,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ASHFORD INVEST & TRADE INC","customerCountry":"BRAZIL","quantity":"37.00","actualQuantity":"37","unit":"KGS","unitRateFc":"1205.1","totalValueFC":"44320.8","currency":"USD","unitRateINR":98459.540540540547,"date":"14-Jun-2023","totalValueINR":"3643003","totalValueInUsd":"44320.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4008694","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690223400,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ASHFORD INVEST & TRADE INC","customerCountry":"BRAZIL","quantity":"43.00","actualQuantity":"43","unit":"KGS","unitRateFc":"1188.6","totalValueFC":"50495.4","currency":"USD","unitRateINR":96516.209302325587,"date":"25-Jul-2023","totalValueINR":"4150197","totalValueInUsd":"50495.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4011071","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692642600,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ASHFORD INVEST & TRADE INC","customerCountry":"BRAZIL","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1185.7","totalValueFC":"88246.9","currency":"USD","unitRateINR":97467.279999999999,"date":"22-Aug-2023","totalValueINR":"7310046","totalValueInUsd":"88246.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4012668","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692642600,"product":"TESTOSTERONE UNDECANOATE","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ASHFORD INVEST & TRADE INC","customerCountry":"BRAZIL","quantity":"149.00","actualQuantity":"149","unit":"KGS","unitRateFc":"1245.5","totalValueFC":"184154.4","currency":"USD","unitRateINR":102380.37583892618,"date":"22-Aug-2023","totalValueINR":"15254676","totalValueInUsd":"184154.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4012667","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720031400,"product":"(ACTIVE PHARMACEUTICAL INGREDIENTS) TESTOSTERONE UNDECANOATE","address":"GHANSHYAM INDL. ESTATE, 11\/II-B,","city":"MUMBAI, MAHARASHTRA.","supplier":"TECHNO EXPORT","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"TO THE ORDER OF","customerCountry":"SINGAPORE","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"520","totalValueFC":"500.2","currency":"USD","unitRateINR":41810.769999999997,"date":"04-Jul-2024","totalValueINR":"41810.77","totalValueInUsd":"500.2","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"2177790","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"GHANSHYAM INDL. ESTATE, 11\/II-B,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721068200,"product":"PHARMACEUTICALS RAW MATERIALS TESTOSTERONE UNDECANOATE","address":"1004, UNIQUE TOWER, GAIWADI IND ESTATE,NR KAMAT CLUB","city":"MUMBAI","supplier":"SHAKTI LIFESCIENCE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"TO THE ORDER OF","customerCountry":"PAKISTAN","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"495","totalValueFC":"12238.1","currency":"USD","unitRateINR":40919.959999999999,"date":"16-Jul-2024","totalValueINR":"1022999","totalValueInUsd":"12238.1","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"2443946","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"1004, UNIQUE TOWER, GAIWADI IND ESTATE,NR KAMAT CLUB, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727980200,"product":"TESTOSTERONE UNDECANOATE GRADE:IH TEMP:25-30 DEGREE (AS PER INVOICE)","address":"PLOT NO 23 TO 26","city":"SOJITRA","supplier":"ANDROST BIOTECH INDIA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"HILARION TRADING IMPORTACAO ","customerCountry":"BRAZIL","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1050","totalValueFC":"3115.3","currency":"USD","unitRateINR":87255,"date":"04-Oct-2024","totalValueINR":"261765","totalValueInUsd":"3115.3","indian_port":"Ahmedabad Air","hs_no":"29372900","bill_no":"4566951","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"PLOT NO 23 TO 26, SOJITRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641321000,"product":"TESTOSTERONE UNDECANOATE (LICENSE VALID UP TO 17-11-2024)","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"","supplier":"STEROID SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2000","unit":"GMS","unitRateFc":"2.9","totalValueFC":"5886.4","currency":"USD","unitRateINR":"219.3","date":"05-Jan-2022","totalValueINR":"438500","totalValueInUsd":"5886.4","indian_port":"Biocon-SEZ","hs_no":"29372900","bill_no":"1000133","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671733800,"product":"TESTOSTERONE UNDECANOATE CHEMICAL NAME 8R,9S,10R,13S,14S,17S-10,13-DIMETHYL-3-OXO-1,2,6,7,8,9,11,12,14,15,16,17- DODEC","address":"12-Dec Shakti Nagar","city":"Delhi","supplier":"HUASUN PHARMACEUTICAL CO. LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"COOPER LAB","customerCountry":"INDIA","quantity":"3.30","actualQuantity":"3.3","unit":"KGS","unitRateFc":"430","totalValueFC":"1438.7","currency":"USD","unitRateINR":"35926.5","date":"23-Dec-2022","totalValueINR":"118557.45","totalValueInUsd":"1438.7","indian_port":"DELHI AIR","hs_no":"29371900","bill_no":"3868978","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12-Dec Shakti Nagar"}]
    15-Mar-2021
    04-Oct-2024
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    ABOUT THIS PAGE

    Testosterone Undecanoate Manufacturers

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

    Testosterone Undecanoate Suppliers

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

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

    Testosterone Undecanoate USDMF

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

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

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

    Testosterone Undecanoate KDMF

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

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

    After submitting a Testosterone Undecanoate 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 Testosterone Undecanoate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Testosterone Undecanoate suppliers with KDMF on PharmaCompass.

    Testosterone Undecanoate WC

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

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

    Testosterone Undecanoate 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 Testosterone Undecanoate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Testosterone Undecanoate GMP

    Testosterone Undecanoate 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 Testosterone Undecanoate 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 Testosterone Undecanoate GMP manufacturer or Testosterone Undecanoate GMP API supplier for your needs.

    Testosterone Undecanoate CoA

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

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

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