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Chemistry

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Also known as: Phenoxymethylpenicillin, Penicillin phenoxymethyl, Oracillin, 87-08-1, V-cillin, Phenomycilline
Molecular Formula
C16H18N2O5S
Molecular Weight
350.4  g/mol
InChI Key
BPLBGHOLXOTWMN-MBNYWOFBSA-N
FDA UNII
Z61I075U2W

Penicillin V
A broad-spectrum penicillin antibiotic used orally in the treatment of mild to moderate infections by susceptible gram-positive organisms.
Penicillin v is a Penicillin-class Antibacterial.
1 2D Structure

Penicillin V

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,5R,6R)-3,3-dimethyl-7-oxo-6-[(2-phenoxyacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
2.1.2 InChI
InChI=1S/C16H18N2O5S/c1-16(2)12(15(21)22)18-13(20)11(14(18)24-16)17-10(19)8-23-9-6-4-3-5-7-9/h3-7,11-12,14H,8H2,1-2H3,(H,17,19)(H,21,22)/t11-,12+,14-/m1/s1
2.1.3 InChI Key
BPLBGHOLXOTWMN-MBNYWOFBSA-N
2.1.4 Canonical SMILES
CC1(C(N2C(S1)C(C2=O)NC(=O)COC3=CC=CC=C3)C(=O)O)C
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)COC3=CC=CC=C3)C(=O)O)C
2.2 Other Identifiers
2.2.1 UNII
Z61I075U2W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Apocillin

2. Beromycin

3. Beromycin, Penicillin

4. Berromycin, Penicillin

5. Betapen

6. Fenoxymethylpenicillin

7. Pen Vk

8. Penicillin Beromycin

9. Penicillin Berromycin

10. Penicillin V Potassium

11. Penicillin V Sodium

12. Penicillin Vk

13. Penicillin, Phenoxymethyl

14. Phenoxymethyl Penicillin

15. Phenoxymethylpenicillin

16. Potassium, Penicillin V

17. Sodium, Penicillin V

18. V Cillin K

19. V Sodium, Penicillin

20. V-cillin K

21. Vcillin K

22. Vegacillin

2.3.2 Depositor-Supplied Synonyms

1. Phenoxymethylpenicillin

2. Penicillin Phenoxymethyl

3. Oracillin

4. 87-08-1

5. V-cillin

6. Phenomycilline

7. Fenospen

8. Vebecillin

9. Distaquaine V

10. Phenoxymethyl Penicillin

11. Beromycin

12. Phenoxymethylenepenicillinic Acid

13. Phenoximethylpenicillinum

14. Phenoxymethylpenicillinum

15. Fenoximetilpenicilina

16. Pen-v

17. Phenoxymethylpenicillinic Acid

18. Phenoxymethylpenicilline

19. Phenopenicillin

20. 6-phenoxyacetamidopenicillanic Acid

21. Meropenin

22. Fenossimetilpenicillina [dcit]

23. Phenoxomethylpenicillin

24. Penapar-vk

25. Phenocillin

26. Stabicillin

27. Fenacilin

28. Oratren

29. Apopen

30. Ospen

31. Fenoximetilpenicilina [inn-spanish]

32. Eskacillian V

33. V-tablopen

34. Pen-vee

35. Acipen V

36. Pen-oral

37. V-cyline

38. Penicillin-vk

39. V-cil

40. (2s,5r,6r)-3,3-dimethyl-7-oxo-6-[(2-phenoxyacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

41. Chebi:27446

42. Calcipen

43. Rocilin

44. (2s,5r,6r)-3,3-dimethyl-7-oxo-6-[(phenoxyacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

45. Eskacillin V

46. Crystapen V

47. V-cylina

48. Phenoxymethylpenicillin (inn)

49. Phenoxymethylpenicillin [inn]

50. (2s,5r,6r)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1- Azabicyclo(3.2.0)heptane-2-carboxylic Acid

51. (2s,5r,6r)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid

52. Z61i075u2w

53. P-mega-tablinen

54. (2s,5r,6r)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

55. Pnv

56. Fenossimetilpenicillina

57. Penicillin V [usan]

58. Phenoxymethylpenicillin 100 Microg/ml In Acetonitrile

59. Penicillanic Acid, 6-phenoxyacetamido-

60. Phenoxymethylpenicillinic Acid Potassium Salt

61. (2s,5r,6r)-3,3-dimethyl-7-oxo-6-{[(phenyloxy)acetyl]amino}-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

62. Phenoxymethylpenicilline [inn-french]

63. Phenoxymethylpenicillinum [inn-latin]

64. Ccris 752

65. V-cillin (tn)

66. Penicillin V (usp)

67. Hsdb 6314

68. Phenoxomethylpenicillanyl

69. Phenoxymethylpenicillanyl

70. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-

71. 132-98-9

72. Einecs 201-722-0

73. Brn 0096259

74. Penicillin V [usan:usp]

75. Unii-z61i075u2w

76. Penicillinv

77. Penicillin-v-potassium

78. 3,3-dimethyl-7-oxo-6-((phenyloxyacetyl)amino)-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid

79. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((phenoxyacetyl)amino)-, (2s-(2alpha,5alpha,6beta))-

80. Pc Pen Vk

81. Spectrum_001007

82. Spectrum2_000495

83. Spectrum3_000543

84. Spectrum4_000472

85. Spectrum5_001409

86. Chembl615

87. Epitope Id:115011

88. Epitope Id:116056

89. Penicillin V [mi]

90. Penicillin V [hsdb]

91. Schembl49223

92. Bspbio_002185

93. Kbiogr_000944

94. Kbioss_001487

95. 4-27-00-05884 (beilstein Handbook Reference)

96. Mls001304105

97. Divk1c_000779

98. Spbio_000389

99. Penicillin V [usp-rs]

100. Dtxsid3023429

101. Schembl22099709

102. Chebi:53706

103. Gtpl10920

104. Hy-b0975a

105. Kbio1_000779

106. Kbio2_001487

107. Kbio2_004055

108. Kbio2_006623

109. Kbio3_001685

110. Ninds_000779

111. Glxc-25717

112. Penicillin V [orange Book]

113. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((phenoxyacetyl)amino)-, (2s,5r,6r)-

114. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((phenoxyacetyl)amino)-, (2s-(2.alpha.,5.alpha.,6.beta.))-

115. Zinc3831282

116. 2,2-dimethyl-6beta-[(phenoxyacetyl)amino]penam-3alpha-carboxylic Acid

117. Bdbm50370584

118. Penicillin V [usp Monograph]

119. 3,3-dimethyl-6beta-[(phenoxyacetyl)amino]penam-2alpha-carboxylic Acid (pin)

120. Akos015969737

121. Db00417

122. Phenoxymethylpenicillin [mart.]

123. Idi1_000779

124. Phenoxymethylpenicillin [who-dd]

125. Phenoxymethylpenicillin [who-ip]

126. Phenoxymethyl Penicillinic Acid*free Acid

127. Smr000539431

128. Sbi-0051477.p003

129. Ab00514745

130. Cs-0013728

131. Phenoxymethylpenicillin [ep Monograph]

132. Phenoxymethylpenicillin For System Suitability

133. C08126

134. D05411

135. Phenoxymethylpenicillinum [who-ip Latin]

136. Q422215

137. W-109316

138. Brd-k43966364-237-02-2

139. Brd-k43966364-237-03-0

140. 6beta-phenoxyacetamido-2,2-dimethylpenam-3alpha-carboxylic Acid

141. Phenoxymethylpenicillin, Antibiotic For Culture Media Use Only

142. Penicillin V, United States Pharmacopeia (usp) Reference Standard

143. Phenoxymethylpenicillin, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 350.4 g/mol
Molecular Formula C16H18N2O5S
XLogP32.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass350.09364285 g/mol
Monoisotopic Mass350.09364285 g/mol
Topological Polar Surface Area121 Ų
Heavy Atom Count24
Formal Charge0
Complexity547
Isotope Atom Count0
Defined Atom Stereocenter Count3
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 NamePenicillin-vk
Active IngredientPenicillin v potassium
Dosage FormTablet; For solution
RouteOral
Strengtheq 250mg base/5ml; eq 500mg base; eq 250mg base; eq 125mg base/5ml
Market StatusPrescription
CompanyTeva

2 of 2  
Drug NamePenicillin-vk
Active IngredientPenicillin v potassium
Dosage FormTablet; For solution
RouteOral
Strengtheq 250mg base/5ml; eq 500mg base; eq 250mg base; eq 125mg base/5ml
Market StatusPrescription
CompanyTeva

4.2 Therapeutic Uses

Penicillins

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Penicillin V is used for the treatment of mild to moderately severe infections caused by organisms susceptible to low concentrations of the drug or for prophylaxis of certain streptococcal infections.

American Hospital Formulary Service-Drug Information 85. Bethesda, MD: American Society Hospital Pharmacists, 1985. (Plus supplements A & B, 1985)., p. 8:12.16 153


Penicillin V /is/ indicated in the treatment of acute otitis media caused by susceptible organisms. /Included in US product labeling/

USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 2149


Penicillin V /is/ indicated in the treatment of bacterial pharyngitis cuased by susceptible organisms. /Included in US product labeling/

USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 2149


For more Therapeutic Uses (Complete) data for PENICILLIN V (21 total), please visit the HSDB record page.


4.3 Drug Warning

The most important biological effect of penicillin, unrelated to hypersensitivity or to "toxic" reaction, is alteration of bacterial flora in areas of the body to which it gains access. Regardless of the route by which the drug is administered, but most strikingly when it is given by mouth, penicillin changes the composition of the microflora by eliminating sensitive microorganisms. ... In some persons ... suprainfection results from the changes in flora. /Penicillin/

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1150


Fever and even vascular collapse and death may follow the use of penicillin in syphilis. This is one manifestation of the Jarisch-Herxheimer reaction. It is thought to be due to hypersensitivity to antigens released during rapid and massive lysis of spirochetes. /Penicillin/

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1150


Contraceptive failure and pregnancies attributed to the concurrent use of penicillins ... have been reported on a number of occasions. ... Mechanism /is/ not understood. It has been observed that ampicillin given to women in latter wk of pregnancy decreases urinary oestriol levels ... & phenoxymethylpenicillin behaves in a similar way ...

Stockley, I.H. Drug Interactions. Boston: Blackwell Scientific Publications, 1981., p. 272


Individual with phenylketonuria (ie, homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be warned that Warner Chilcott's penicillin V potassium powder for oral soln contains aspartame ... which is metabolized in the GI tract to phenylalanine following oral administration.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 255


For more Drug Warnings (Complete) data for PENICILLIN V (16 total), please visit the HSDB record page.


4.4 Drug Indication

Indicated for the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms, with the use of bacteriological studies (including sensitivity tests) and clinical response. Phenoxymethylpenicillin may be used for the treatment of: - mild to moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas caused by Streptococcus without bacteremia - mild to moderately severe infections of the respiratory tract caused by Pneumococcus - mild infections of the skin and soft tissues caused by penicillin G-sensitive Staphylococcus - mild to moderately severe infections of the oropharynx caused by Fusospirochetosis, including Vincents gingivitis and pharyngitis, usually respond to oral penicillin therapy **Off-label** Indicated for use as prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Phenoxymethylpenicillin works against penicillin-sensitive microorganisms with bactericidal effects. It targets the bacteria during its active multiplication stage by interfering with bacterial cell wall peptidoglycan synthesis. _In vitro_, phenoxymethylpenicillin was shown to be active against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L and M), and pneumococci, as well as _Corynebacterium diphtheriae_, _Bacillus anthracis_, Clostridia, _Actinomyces bovis_, _Streptobacillus moniliformis_, _Listeria monocytogenes_, _Leptospira_, _Neisseria gonorrhoeae_, and _Treponema pallidum_.


5.2 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
PENICILLIN V
5.3.2 FDA UNII
Z61I075U2W
5.3.3 Pharmacological Classes
Chemical Structure [CS] - Penicillins
5.4 ATC Code

J01CE02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01C - Beta-lactam antibacterials, penicillins

J01CE - Beta-lactamase sensitive penicillins

J01CE02 - Phenoxymethylpenicillin


5.5 Absorption, Distribution and Excretion

Absorption

Upon oral administration, phenoxymethylpenicillin is rapidly but incompletely absorbed. The bioavailability of phenoxymethylpenicillin ranges from 25 to 60%. Compared to the free acid form of the drug, the calcium or potassium salts of phenoxymethylpenicillin displays better absorption profiles. It is reported that fasting state enhances the drug absorption. The peak plasma concentrations of 200 to 700 ng/mL are achieved in 2 hours following an oral dose of 125 mg. Following an oral dose of 500 mg, the peak plasma concentrations of 3 to 5 g/mL are reached in 30 to 60 minutes post-dose.


Route of Elimination

While the drug is rapidly excreted, only 25% of the total dose is detected in the urine. Renal excretion may be delayed in neonates, young infants, and patients with renal impairment.


Volume of Distribution

Following intravenous administration, the volume of distribution at steady state was 35.4 L. Small amounts of the drug can be found in various tissues, with the highest amount found in the kidneys, with lesser amounts in the liver, skin, and intes tines. Phenoxymethylpenicillin was found in the cerebrospinal fluid. Phenoxymethylpenicillin was detectable in the placenta and human breast milk.


A dose of 1,000,000 units of the acid gives peak plasma levels of about 2 to 3 ug/ml ...

Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 1142


Approx 60-73% of an oral dose of penicillin V or penicillin V potassium is absorbed from the GI tract in healthy, fasting adults. Following oral administration of a single dose of penicillin V or penicillin V potassium in fasting children or adults, peak serum concn of penicillin V are generally attained within 30-60 min. Peak serum penicillin V concn are attained sooner and are slightly higher following administration of the potassium salt than the free acid.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 254


Following oral administration of a single 125-mg tablet of penicillin V potassium in healthy, fasting adults in one study, serum penicillin V concn averaged 1.2, 1.2, 0.5, and 0.1 ug/ml @ 30 min, 1 hr, 2 hr, and 4 hr, respectively, after the dose. Oral administration of a single 250-mg tablet of the drug in healthy, fasting adults results in serum penicillin V concn averaging 2.1-2.8, 2.3-2.7, 0.8-0.9, and 0.1-0.2 ug/ml @ 30 min, 1 hr, 2 hr, and 4 hr, respectively, after the dose. Following oral administration of a single 500-mg tablet of penicillin V potassium in healthy, fasting adults, serum penicillin V concn average 4.7-5, 4.9-6.3, 2.3-3, and 0.04-0.1 ug/ml @ 30 min, 1 hr, 2 hr, and 6 hr, respectively, after the dose.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 254


Variable results have been obtained in studies evaluating the effect of food on GI absorption of penicillin V and penicillin V potassium. In most studies, presence of food in the GI tract resulted in lower and delayed peak serum concn of penicillin V, although the total amt of drug absorbed was unaffected. However, results of several studies in children 2 mo to 5 yr of age indicate that both the peak serum concn and the area under the serum concn-time curve (AUC) are decreased when penicillin V potassium is administered with or immediately prior to milk or food.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 255


For more Absorption, Distribution and Excretion (Complete) data for PENICILLIN V (8 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

About 35-70% of an oral dose is metabolized to penicilloic acid, an inactive metabolite. Small amounts of 6-aminopenicillanic acid have been recovered in the urine of patients on penicillin G. A small percentage of the drug appears to be hydroxylated into one or more active metabolites, which are also excreted via urine.


Approximately 35-70% of an oral dose of penicillin V or penicillin V potassium is metabolized to penicilloic acid which is microbiologically inactive. Small amt of 6-aminopenicillanic acid (6-APA) have also been found in urine of patients receiving penicillin V. In addition, the drug appears to be hydroxylated to a small extent to one or more microbiologically active metabolites which are also excreted in urine.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 255


5.7 Biological Half-Life

Upon oral administration, the half-life is about 30 minutes. It can last up to 4 hours in patients with renal impairment.


The serum half-life of penicillin V in adults with normal renal function is reportedly 0.5 hr.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 255


5.8 Mechanism of Action

Phenoxymethylpenicillin inhibits the biosynthesis of cell wall mucopeptide by binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which are critical in the cell wall synthesis and maintenance, as well as cell division. This disrupts the third and last stage of bacterial cell wall synthesis. This subsequently leads to cell lysis.


Penicillins and breakdown products of penicillins act as haptens after their covalent reaction with proteins. The most important antigenic intermediate of penicillin appears to be the penicilloyl moiety, which is formed when the beta-lactam ring is opened. This is considered to be the major (predominant) determinant of penicillin allergy. /Penicillins/

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1148


Penicillin is known to interfere with synthesis of N-acetylmuramic acid mucopeptides and teichoic acids which are part of cell-wall material. ... Under favorable conditions penicillin exerts direct bactericidal action, & successful penicillin therapy may be relatively independent of immunity mechanisms of the host. /Penicillins/

Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 1135


The penicillins and their metabolites are potent immunogens because of their ability to combine with proteins and act as haptens for acute antibody-mediated reactions. The most frequent (about 95 percent) or "major" determinant of penicillin allergy is the penicilloyl determinant produced by opening the beta-lactam ring of the penicillin. This allows linkage of the penicillin to protein at the amide group. "Minor" determinants (less frequent) are the other metabolites formed, including native penicillin and penicilloic acids. /Penicillins/

Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 953


Bactericidal; inhibit bacterial cell wall synthesis. Action is dependent on the ability of penicillins to reach and bind penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. Penicillin-binding proteins (which include transpeptidases, carboxypeptidases, and endopeptidases) are enzymes that are involved in the terminal stages of assembling the bacterial cell wall and in reshaping the cell wall during growth and division. Penicillins bind to, and inactivate, penicillin-binding proteins, resulting in the weakening of the bacterial cell wall and lysis. /Penicillins/

USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 2150


API Reference Price

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D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1415000","totalValueFC":"306.1","currency":"USD","unitRateINR":"128603300","date":"30-Oct-2024","totalValueINR":"25720.66","totalValueInUsd":"306.1","indian_port":"Hyderabad Air","hs_no":"29411090","bill_no":"6428123","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK, MD, US 21704 SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"PENICILLIN V POTASSIUM FOR DIRECT COMPRESSION IP\/BP\/ CEP GRADE R2 CEP-1994-012-REV 06(PHENOXYMETHYL PENICILLIN POTASSIUM","address":"A-5, MEGH MALHAR, GAVAND PATH,","city":"THANE ,MAHARASHTRA","supplier":"SANDOZ B2B","supplierCountry":"AUSTRIA","foreign_port":"LINZ","customer":"MILAN LABORATORIES INDIA PVT. 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16-Jan-2021
27-Nov-2024
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ABOUT THIS PAGE

Penicillin V Manufacturers

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

Penicillin V Suppliers

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

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

Penicillin V USDMF

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

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

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

Penicillin V 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 Penicillin V Drug Master File in Japan (Penicillin V JDMF) empowers Penicillin V 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 Penicillin V JDMF during the approval evaluation for pharmaceutical products. At the time of Penicillin V 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 Penicillin V suppliers with JDMF on PharmaCompass.

Penicillin V GMP

Penicillin V 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 Penicillin V 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 Penicillin V GMP manufacturer or Penicillin V GMP API supplier for your needs.

Penicillin V CoA

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

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

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