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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 6 USDMF, 3 CEP/COS, 1 JDMF, 9 EU WC, 7 NDC API, 23 Listed Suppliers, $ API Reference Price

30 API Suppliers
6 USDMF
3 CEP/COS
1 JDMF
9 EU WC
7 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

43 FDF Dossiers, 10 FDA Orange Book, 16 Europe, 3 Canada, 4 South Africa, 10 Listed Dossiers

43 FDF Dossiers
10 FDA Orange Book
16 Europe
3 Canada
4 South Africa
10 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 8 Nanjing Well Pharmaceutical, 4 Actylis, 18 BASF, 1 Clariant, 4 Corel Pharma Chem, 1 Finar, 3 Gangwal Chemicals, 6 Kerry, 2 Lubrizol Life Science Health, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Seppic, 2 Valens Pharmachem

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1 SPI Pharma
2 Seqens
8 Nanjing Well Pharmaceutical
4 Actylis
18 BASF
1 Clariant
4 Corel Pharma Chem
1 Finar
3 Gangwal Chemicals
6 Kerry
2 Lubrizol Life Science Health
2 Nanjing Bold Chemical
2 Nomisma Healthcare
2 Seppic
2 Valens Pharmachem

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excipientsByApplications
28 Topical
19 Solubilizers
10 Thickeners and Stabilizers
9 Emulsifying Agents
7 Parenteral
6 Controlled & Modified Release
6 Co-Processed Excipients
4 Film Formers & Plasticizers
4 Granulation
4 Direct Compression
3 Coating Systems & Additives
2 Surfactant & Foaming Agents
2 Lubricants & Glidants
2 Taste Masking
1 API Stability Enhancers
1 Rheology Modifiers
1 Chewable & Orodispersible Aids

DIGITAL CONTENT

7 NEWS #PharmaBuzz

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7 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

13 Finished Drug Prices

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13 Finished Drug Prices

MARKET PLACE

10 APIs, 1 FDF Dossiers

marketPlace
10 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 5 Others

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3 EDQM
3 USP
5 Others

CHSD Prilocaine

Synopsis

ACTIVE PHARMA INGREDIENTS

30

API Suppliers

6

USDMF

3

CEP/COS

CEP/COS Certifications

1

JDMF

9

EU WC

0

KDMF

7

NDC API

0

VMF

23

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 194

MARKET PLACE

10

API

1

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

43

FDF Dossiers

10

FDA Orange Book

FDA (Orange Book)

16

Europe

3

Canada

0

Australia

4

South Africa

10

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

3

EDQM

3

USP

0

JP

5

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

7

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

NA

Annual Reports (USD Million)

NA

Finished Drug Prices

58 RELATED EXCIPIENT COMPANIES

109EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 721-50-6, Propitocaine, Citanest, Prilocainum, Prilocaine base, N-(2-methylphenyl)-2-(propylamino)propanamide

Molecular Formula

C₁₃H₂₀N₂O

Molecular Weight

220.31 g/mol

InChI Key

MVFGUOIZUNYYSO-UHFFFAOYSA-N

FDA UNII

046O35D44R

Prilocaine

A local anesthetic that is similar pharmacologically to LIDOCAINE. Currently, it is used most often for infiltration anesthesia in dentistry.

Prilocaine is an Amide Local Anesthetic. The physiologic effect of prilocaine is by means of Local Anesthesia.

1 2D Structure

Prilocaine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-(2-methylphenyl)-2-(propylamino)propanamide

2.1.2 InChI

InChI=1S/C13H20N2O/c1-4-9-14-11(3)13(16)15-12-8-6-5-7-10(12)2/h5-8,11,14H,4,9H2,1-3H3,(H,15,16)

2.1.3 InChI Key

MVFGUOIZUNYYSO-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCCNC(C)C(=O)NC1=CC=CC=C1C

2.2 Other Identifiers

2.2.1 UNII

046O35D44R

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Citanest

2. Citanest Octapressin

3. Prilocaine Hydrochloride

4. Propitocaine

5. Xylonest

2.3.2 Depositor-Supplied Synonyms

1. 721-50-6

2. Propitocaine

3. Citanest

4. Prilocainum

5. Prilocaine Base

6. N-(2-methylphenyl)-2-(propylamino)propanamide

7. Astra 1515

8. O-methyl-2-propylaminopropionanilide

9. Propanamide, N-(2-methylphenyl)-2-(propylamino)-

10. Prilocaina

11. 2-(propylamino)-o-propionotoluidide

12. O-propionotoluidide, 2-(propylamino)-

13. Astra 1512

14. O-methyl-alpha-propylaminopropionanilide

15. 2-methyl-alpha-propylaminopropionanilide

16. Alpha-n-propylamino-2-methylpropionanilide

17. Nsc 40027

18. Propitocaine (jan)

19. Chebi:8404

20. 2-(propylamino)-n-(o-tolyl)propanamide

21. 2-methyl-.alpha.-propylaminopropionanilide

22. Nsc-40027

23. Astra-1512

24. Astra-1515

25. O-propionotuluidide, 2-propylamino-

26. 046o35d44r

27. Prilocaine [usan]

28. Propitocaine [jan]

29. Prilocainum [inn-latin]

30. Prilocaina [inn-spanish]

31. L-67

32. (+/-)-prilocaine

33. Hsdb 3386

34. Prilocaine (usp/inn)

35. O-propionotoluidide, 2-propylamino-

36. Einecs 211-957-0

37. Brn 2108498

38. Prilotekal

39. Unii-046o35d44r

40. Prilocaine [usan:usp:inn:ban]

41. N-(2-methylphenyl)-n2-propylalaninamide

42. Spectrum_001649

43. L 67

44. Prilocaine [mi]

45. Prilocaine [inn]

46. N-(2-methylphenyl)-n(2)-propylalaninamide

47. N-(2-methylphenyl)-n~2~-propylalaninamide

48. Prestwick0_000199

49. Prestwick1_000199

50. Prestwick2_000199

51. Prestwick3_000199

52. Spectrum2_001549

53. Spectrum3_001052

54. Spectrum4_001192

55. Spectrum5_001175

56. (.+/-.)-prilocaine

57. Prilocaine [hsdb]

58. Prilocaine [vandf]

59. Prilocaine [mart.]

60. Chembl1194

61. Prilocaine [usp-rs]

62. Prilocaine [who-dd]

63. Lopac0_001005

64. Schembl25467

65. Bspbio_000157

66. Bspbio_002604

67. Kbiogr_001883

68. Kbioss_002129

69. Divk1c_000846

70. Spbio_001398

71. Spbio_002078

72. Bpbio1_000173

73. Gtpl7276

74. Dl-(+/-)-prilocaine

75. Emla Component Prilocaine

76. Dtxsid7031955

77. Prilocaine [orange Book]

78. Kbio1_000846

79. Kbio2_002129

80. Kbio2_004697

81. Kbio2_007265

82. Kbio3_001824

83. Prilocaine [ep Monograph]

84. Ninds_000846

85. Oraqix Component Prilocaine

86. Hms3604h09

87. Hms3651m13

88. Hms3884a04

89. Prilocaine [usp Monograph]

90. Act04759

91. Fortacin Component Prilocaine

92. Hy-b0137

93. Nsc40027

94. Prilocaine Component Of Emla

95. Bdbm50225477

96. Mfcd00048681

97. S1619

98. Stl257086

99. 2-(propylamino)-n-o-tolylpropanamide

100. Prilocaine Component Of Oraqix

101. Akos015889404

102. Ac-2100

103. Ccg-205085

104. Cs-1929

105. Db00750

106. Prilocaine Component Of Fortacin

107. Sdccgsbi-0050978.p004

108. Idi1_000846

109. Ncgc00015860-02

110. Ncgc00015860-03

111. Ncgc00015860-15

112. Ncgc00162312-01

113. As-14851

114. O-methyl-.alpha.-propylaminopropionanilide

115. Sbi-0050978.p003

116. Db-055611

117. Ab00053665

118. Ft-0603506

119. Ft-0660568

120. Sw196783-3

121. .alpha.-n-propyl-amino-2-methylpropionanilide

122. 86p818

123. C07531

124. D00553

125. Ab00053665-12

126. Ab00053665_13

127. Ab00053665_14

128. A837435

129. N-(2-methylphenyl)-2-(propylamino)propanamide #

130. Q413598

131. N-(2-methylphenyl)-2-(propylamino)propanimidic Acid

132. Q-100809

133. Brd-a53952395-003-05-3

134. Brd-a53952395-003-15-2

135. (+/-)-n-(2-propylaminopropionyl)-2-toluidine

136. N-(2,6-dimethylphenyl)-2-(propylamino)propanamide

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₃H₂₀N₂O
Molecular Weight	220.31 g/mol
XLogP3	2.1
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	5
Exact Mass	220.157563266 g/mol
Monoisotopic Mass	220.157563266 g/mol
Topological Polar Surface Area	41.1 Å²
Heavy Atom Count	16
Formal Charge	0
Complexity	218
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Therapeutic Uses

Anesthetics, Local

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

AN AGENT CHEMICALLY SIMILAR TO LIDOCAINE & MEPIVACAINE USED FOR LOCAL & REGIONAL-BLOCK ANESTHESIA. IN ONSET OF ACTION & EFFECTIVENESS 1-3% SOLN... EQUIVALENT TO LIDOCAINE & MEPIVACAINE IN 1%-2% CONCN. ITS DURATION OF ACTION IS INTERMEDIATE TO SHORTER-ACTING LIDOCAINE & LONGER-ACTING MEPIVACAINE. /PRILOCAINE HCL/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 994

PRILOCAINE HYDROCHLORIDE ... HAS BEEN EMPLOYED ... FOR SPINAL ANESTHESIA. /PRILOCAINE HCL/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 390

... ACT ON ANY PART OF THE NERVOUS SYSTEM & ON EVERY TYPE OF NERVE FIBER. /LOCAL ANESTHETICS/

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 331

For more Therapeutic Uses (Complete) data for PRILOCAINE (10 total), please visit the HSDB record page.

4.2 Drug Warning

AS WITH OTHER LOCAL ANESTHETICS, PRILOCAINE HCL IS CONTRAINDICATED IN PRESENCE OF SHOCK, SEVERE CARDIOVASCULAR DISEASE, OR HEART BLOCK. /PRILOCAINE HCL/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 994

... SHOULD NOT BE ADMIN TO PT WITH IDIOPATHIC OR CONGENITAL METHEMOGLOBINEMIA, ANEMIA, OR CARDIAC OR VENTILATORY FAILURE WITH HYPOXIA; IT SHOULD BE USED WITH CAUTION FOR CONTINUOUS EPIDURAL ANESTHESIA SINCE THE METHEMOGLOBINEMIC EFFECT OF INDIVIDUAL DOSES IS ADDITIVE. /PRILOCAINE HCL/

American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 170

IN PRESENCE OF HEMORRHAGE, SYMPATHETIC BLOCK PRODUCED BY EPIDURAL ANESTHESIA BECOMES EXTREMELY SIGNIFICANT & MAY RESULT IN RAPID & DELETERIOUS CIRCULATORY CHANGES. /LOCAL ANESTHETICS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 399

TWO OUTSTANDING DANGERS /OF CAUDAL ANESTHESIA/ ARE (1) INTRODUCING NEEDLE INTO VENOUS PLEXUS LINING SACRAL CANAL, WITH RESULTANT INTRAVASCULAR INJECTION OF DRUG, & (2) PENETRATING DURA, WITH DEVELOPMENT OF HIGH LEVEL OF SPINAL ANESTHESIA. /LOCAL ANESTHETICS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 399

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

4.3 Drug Indication

Used as a local anaesthetic and is often used in dentistry.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Prilocaine binds to the intracellular surface of sodium channels which blocks the subsequent influx of sodium into the cell. Action potential propagation and never function is, therefore, prevented. This block is reversible and when the drug diffuses away from the cell, sodium channel function is restored and nerve propagation returns.

5.2 MeSH Pharmacological Classification

Anesthetics, Local

Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

PRILOCAINE

5.3.2 FDA UNII

046O35D44R

5.3.3 Pharmacological Classes

Physiologic Effects [PE] - Local Anesthesia

5.4 ATC Code

N01BB04

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

N - Nervous system

N01 - Anesthetics

N01B - Anesthetics, local

N01BB - Amides

N01BB04 - Prilocaine

5.5 Absorption, Distribution and Excretion

Route of Elimination

Prilocaine is metabolized in both the liver and the kidney and excreted via the kidney.

/CONCERNING/ HYDROLYSIS OF AMIDE BOND OF PRILOCAINE... PLASMA CONCN OF R-(-)-ENANTIOMER WERE FOUND TO BE LOWER THAN THOSE OF THE S-(+)-ENANTIOMER AFTER IV ADMIN TO CAT. IN VITRO STUDIES USING LIVER PREPN FROM VARIOUS MAMMALS CONFIRMED THE R-(-)-ISOMER TO BE HYDROLYZED @ MUCH HIGHER RATES THAN THE S-(+) FORM...

Testa, B. and P. Jenner. Drug Metabolism: Chemical & Biochemical Aspects. New York: Marcel Dekker, Inc., 1976., p. 241

THERE IS...MORE RAPID PRODN OF METHEMOGLOBINEMIA BY D-(-) FORM, CAUSED PRESUMABLY BY HIGHER BLOOD LEVELS OF HYDROLYSIS PRODUCT, O-TOLUIDINE.

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 375

PRILOCAINE FETAL/MATERNAL CONCN RATIO: 1.0 /FROM TABLE/

LaDu, B.N., H.G. Mandel, and E.L. Way. Fundamentals of Drug Metabolism and Disposition. Baltimore: Williams and Wilkins, 1971., p. 100

PRILOCAINE DOSE 0.2 G IV GAVE BLOOD CONCN 0.26 MG% @ 0.3 HR & 0.14 MG% @ 0.17 HR; DOSE 0.4 G IV GAVE BLOOD CONCN 0.15 MG% @ 0.12 HR & 0.08 MG% @ 0.33 HR; DOSE 0.4 G EPIDURAL BLOCK GAVE BLOOD CONCN 0.26 MG% @ 0.25 HR (PEAK); DOSE 0.4 G INTERCOSTAL BLOCK GAVE BLOOD CONCN 0.40 MG% @ 0.25 HR. /FROM TABLE/

Sunshine, I. (ed.). CRC Handbook of Analytical Toxicology. Cleveland: The Chemical Rubber Co., 1969., p. 370

5.6 Metabolism/Metabolites

The amide-linked local anesthetics are, in general, degraded by the hepatic endoplasmic reticulum, the initial reactions involving N-dealkylation and subsequent hydrolysis. However, with prilocaine, the initial step is hydrolytic, forming o-toluidine metabolites that can cause methemoglobinemia.

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 338

BIOTRANSFORMATION OF PRILOCAINE...IN RATS GAVE O-TOLUIDINE & N-PROPYLALANINE.

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 1: A Review of the Literature Published Between 1960 and 1969. London: The Chemical Society, 1970., p. 244

5.7 Biological Half-Life

MEPIVACAINE-HCL (I-HCL) & PRILOCAINE-HCL (II-HCL) WERE INFUSED IV 250 MG INTO HEALTHY VOLUNTEERS. T/2 FOR I WAS GENERALLY LONGER THAN II; TOTAL BODY CLEARANCE II CONSISTENTLY GREATER THAN I. II CLEARANCE EXCEEDED NORMAL HEPATIC BLOOD FLOW: EXTRA-HEPATIC METAB SITE IS POSTULATED.

ARTHUR ET AL; BR J ANAESTH 51(6) 481 (1979)

5.8 Mechanism of Action

Prilocaine acts on sodium channels on the neuronal cell membrane, limiting the spread of seizure activity and reducing seizure propagation. The antiarrhythmic actions are mediated through effects on sodium channels in Purkinje fibers.

... BLOCK CONDUCTION IN NERVE PERHAPS BY COMPETING WITH CA @ SOME SITE THAT CONTROLS PERMEABILITY OF MEMBRANE ... CA IS ALSO INVOLVED IN ACTION OF LOCAL ANESTHETICS ON SMOOTH MUSCLE ... & ON ADRENAL MEDULLA ... /LOCAL ANESTHETICS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 380

... PREVENT THE GENERATION & THE CONDUCTION OF THE NERVE IMPULSE. THEIR PRIMARY SITE OF ACTION IS THE CELL MEMBRANE. ... BLOCK CONDUCTION BY DECREASING OR PREVENTING THE LARGE TRANSIENT INCREASE IN THE PERMEABILITY OF EXCITABLE MEMBRANES TO NA+ THAT NORMALLY IS PRODUCED BY A SLIGHT DEPOLARIZATION OF THE MEMBRANE. /LOCAL ANESTHETICS/

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 332

AS ANESTHETIC ACTION PROGRESSIVELY DEVELOPS IN A NERVE, THRESHOLD FOR ELECTRICAL EXCITABILITY INCR & SAFETY FACTOR FOR CONDUCTION DECR; WHEN THIS ACTION IS SUFFICIENTLY WELL-DEVELOPED, BLOCK OF CONDUCTION IS PRODUCED. /LOCAL ANESTHETICS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 380

.../2 POSSIBILITIES:/ ACHIEVE BLOCK BY INCR SURFACE PRESSURE OF LIPID LAYER THAT CONSTITUTES NERVE MEMBRANE...CLOSING PORES THROUGH WHICH IONS MOVE. ... /OR:/ AFFECT PERMEABILITY BY INCR DEGREE OF DISORDER OF MEMBRANE. /LOCAL ANESTHETICS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 382

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NDC API

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Listed Suppliers

01

Shandong Chenghui Shuangda Pharmace...

China

China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

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China

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About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.

Shandong Chenghui Shuangda Pharmaceutical

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02

Nortec Quimica

Brazil

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Not Confirmed

Nortec Quimica is the largest API manufacturer in Latin America.

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Brazil

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About the Company : Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medi...

Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medicines with IFAs developed in Brazil. The company's approach involves leveraging the expertise of major National Research Centers and tapping into the experience of the Brazilian Chemical and Petrochemical Industry. Nortec Química plays a significant role in the Brazilian pharmaceutical landscape and the Unified Health System (SUS), producing APIs for branded, generic, and similar medicines, as well as medicines dedicated to addressing neglected diseases.

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03

ASolution Pharmaceuticals

India

Duphat

Not Confirmed

ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.

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India

Digital Content

About the Company : Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsiveness, and punctuality,...

Since 2010, our dedication to our clientele has been unwavering in addressing pharmaceutical hurdles, regardless of scale. We prioritize integrity, responsiveness, and punctuality, embedding our values into every endeavor. Our aim is to cultivate mutually beneficial relationships with customers, suppliers, and ourselves, fostering sustainable growth. Empowered by visionary leadership and a quality-driven team, ASolution is steadfast in providing innovative solutions to challenges such as Process Development, Optimization, Drug Product and Substance Manufacturing, and more.

ASolution Pharmaceuticals

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04

LGM Pharma

U.S.A

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Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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U.S.A

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

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05

Moehs Iberica

Spain

CPhI WW Frankfurt

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Spain

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About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.

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06

Chynops Pharma

India

Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.

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India

Digital Content

About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...

Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs, Advanced Drug Intermediates, Impurity Standards, Working Standards, KSMs, Industrial Chemicals, Specialty Chemicals, Excipients, Amino Acids, Vitamins, Minerals, Herbal Extracts, Essential Oils, Prebiotics & Probiotics, Veterinary APIs, Solvents, and more from India. Our commitment extends to providing these products to valued customers in both the domestic and global markets.

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07

HRV Global Life Sciences

India

Duphat

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

Digital Content

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

HRV Global Life Sciences

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08

Atman Pharmaceuticals

India

Duphat

Not Confirmed

Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.

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India

Digital Content

About the Company : Atman Pharmaceuticals is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and overseas. ...

Atman Pharmaceuticals is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and overseas. With a heritage spanning over 33 years and vast experience, we have earned a reputation for delivering high-quality and abundant services within the industry. Our emergence as prominent solution providers in the pharmaceutical business underscores our commitment to excellence.

Atman Pharmaceuticals

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Corporate PDF

09

Beijing Fukangren Biopharmaceutical

China

Duphat

Not Confirmed

10

Cerata Pharmaceuticals

India

Duphat

Not Confirmed

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API Reference Price

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Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687890600,"product":"PRILOCAINE BASE USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"SIEGFRIED AG","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"160.00","actualQuantity":"160","unit":"KGS","unitRateFc":"850","totalValueFC":"153544.6","currency":"CHF","unitRateINR":"78880.1","date":"28-Jun-2023","totalValueINR":"12620799.66","totalValueInUsd":"153544.6","indian_port":"BOMBAY AIR","hs_no":"29242990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689791400,"product":"PRILOCAINE BASE","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"NORTEC QUIMICA","supplierCountry":"BRAZIL","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"558.6","totalValueFC":"3038.7","currency":"USD","unitRateINR":"49950","date":"20-Jul-2023","totalValueINR":"249750.06","totalValueInUsd":"3038.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690309800,"product":"PRILOCAINE BASE USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"SIEGFRIED AG","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"153.00","actualQuantity":"153","unit":"KGS","unitRateFc":"850","totalValueFC":"154592.5","currency":"CHF","unitRateINR":"83045.1","date":"26-Jul-2023","totalValueINR":"12705884.78","totalValueInUsd":"154592.5","indian_port":"BOMBAY AIR","hs_no":"29242920","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703701800,"product":"PRILOCAINE BASE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"SIEGFRIED AG","supplierCountry":"SWITZERLAND","foreign_port":"BASLE","customer":"ALEMBIC PHARMACEUTICALS 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LIMITED","customerCountry":"INDIA","quantity":"13.50","actualQuantity":"13.5","unit":"KGS","unitRateFc":"585.3","totalValueFC":"8196.8","currency":"USD","unitRateINR":"50610.1","date":"09-May-2024","totalValueINR":"683235.84","totalValueInUsd":"8196.8","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"3395930","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"RIO DE JANEIRO - GAL","supplierAddress":"RUA DEZESSETE N-200 DIST. INDUSTRIAL DUQUE DE CAXIAS-XEREM DUQUE DE CASIAS-RJ-CP:25250-612 BRAZIL Brazil","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718821800,"product":"PRILOCAINE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"BENECHIM","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"360","totalValueFC":"109061.6","currency":"USD","unitRateINR":"30348","date":"20-Jun-2024","totalValueINR":"9104400","totalValueInUsd":"109061.6","indian_port":"Bombay Air","hs_no":"29242970","bill_no":"4099629","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"RUE RENE MAGRITTE 163 (ZONING NORD)- 7860 LESSINES Brussel (Bruxelles), Belgium Belgium","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720463400,"product":"RE-IMPORT (NCV) PRILOCAINE USP","address":"404 VAIBHAV CHAMBERS, BANDRA-","city":"MUMBAI, MAHARASHTRA","supplier":"NAGASE EUROPA GMBH","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"NAGASE EUROPA GMBH","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"295","totalValueFC":"9606.2","currency":"USD","unitRateINR":"26766.6","date":"09-Jul-2024","totalValueINR":"802996.63","totalValueInUsd":"9606.2","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4420070","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGKOK","supplierAddress":"NO.952 RAMALAND BUILDING 14TH FLOORIV ROAD KWAENG SURIYAWONGSE KHET BABANGKOK TH","customerAddress":"404 VAIBHAV CHAMBERS, BANDRA-"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

Prilocaine Manufacturers

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

Prilocaine Suppliers

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

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

Prilocaine USDMF

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

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

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

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

Prilocaine CEP

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

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

Prilocaine WC

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

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

Prilocaine 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 Prilocaine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Prilocaine GMP

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

Prilocaine CoA

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

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

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