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ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 13 USDMF, 5 CEP/COS, 2 JDMF, 2 EU WC, 1 KDMF, 5 NDC API, 8 Listed Suppliers, $ API Reference Price

22 API Suppliers
13 USDMF
5 CEP/COS
2 JDMF
2 EU WC
1 KDMF
5 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

63 FDF Dossiers, 24 FDA Orange Book, 21 Europe, 4 Canada, 6 Australia, 2 South Africa, 6 Listed Dossiers

63 FDF Dossiers
24 FDA Orange Book
21 Europe
4 Canada
6 Australia
2 South Africa
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 1 DKSH, 1 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 Actylis, 1 Alcedo Pharmachem, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 DFE Pharma, 1 Finar, 3 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 11 Kerry, 9 Microlex e.U, 1 Novo Excipients, 2 Pluviaendo, 1 Prachin Chemical, 12 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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26 Fillers, Diluents & Binders, 15 Film Formers & Plasticizers, 13 Lubricants & Glidants, 12 Direct Compression, 10 Coating Systems & Additives, 7 Taste Masking, 7 Co-Processed Excipients, 7 Parenteral, 6 Granulation, 5 Thickeners and Stabilizers, 4 Topical, 4 Controlled & Modified Release, 3 Solubilizers, 3 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 1 Soft Gelatin, 1 Disintegrants & Superdisintegrants, 1 API Stability Enhancers

excipientsByApplications
26 Fillers, Diluents & Binders
15 Film Formers & Plasticizers
13 Lubricants & Glidants
12 Direct Compression
10 Coating Systems & Additives
7 Taste Masking
7 Co-Processed Excipients
7 Parenteral
6 Granulation
5 Thickeners and Stabilizers
4 Topical
4 Controlled & Modified Release
3 Solubilizers
3 Emulsifying Agents
2 Chewable & Orodispersible Aids
1 Soft Gelatin
1 Disintegrants & Superdisintegrants
1 API Stability Enhancers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

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3 US Medicaid Prescriptions
8 Finished Drug Prices

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5 APIs, 6 FDF Dossiers

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5 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 US Patents

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8 US Patents

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3 EDQM , 1 USP , 3 Others

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1 USP
3 Others

Synopsis

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API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

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$ 351

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FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

3DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

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Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

31,058,082

Annual Reports (USD Million)

Finished Drug Prices

73 RELATED EXCIPIENT COMPANIES

127EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 101-26-8, Mestinon, Regonol, Kalimin, Kalymin, 3-(dimethylcarbamoyloxy)-1-methylpyridinium bromide

Molecular Formula

C₉H₁₃BrN₂O₂

Molecular Weight

261.12 g/mol

InChI Key

VNYBTNPBYXSMOO-UHFFFAOYSA-M

FDA UNII

KVI301NA53

A cholinesterase inhibitor with a slightly longer duration of action than NEOSTIGMINE. It is used in the treatment of myasthenia gravis and to reverse the actions of muscle relaxants.

1 2D Structure

Pyridostigmine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1-methylpyridin-1-ium-3-yl) N,N-dimethylcarbamate;bromide

2.1.2 InChI

InChI=1S/C9H13N2O2.BrH/c1-10(2)9(12)13-8-5-4-6-11(3)7-8;/h4-7H,1-3H3;1H/q+1;/p-1

2.1.3 InChI Key

VNYBTNPBYXSMOO-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C[N+]1=CC=CC(=C1)OC(=O)N(C)C.[Br-]

2.2 Other Identifiers

2.2.1 UNII

KVI301NA53

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Bromide, Pyridostigmine

2. Mestinon

3. Pyridostigmine

2.3.2 Depositor-Supplied Synonyms

1. 101-26-8

2. Mestinon

3. Regonol

4. Kalimin

5. Kalymin

6. 3-(dimethylcarbamoyloxy)-1-methylpyridinium Bromide

7. 3-((dimethylcarbamoyl)oxy)-1-methylpyridin-1-ium Bromide

8. Regonal

9. Mestinon Bromide

10. Pyridostigmini Bromidum

11. Pyridostigmine (bromide)

12. (1-methylpyridin-1-ium-3-yl) N,n-dimethylcarbamate;bromide

13. Nsc-679759

14. Nsc-758435

15. Pyridinium, 3-(((dimethylamino)carbonyl)oxy)-1-methyl-, Bromide

16. Mls000028385

17. 3-[(dimethylcarbamoyl)oxy]-1-methylpyridin-1-ium Bromide

18. Kvi301na53

19. Pyridinium, 3-[[(dimethylamino)carbonyl]oxy]-1-methyl-, Bromide

20. Ro 1-5130

21. 3-hydroxy-1-methylpyridinium Bromide Dimethylcarbamate

22. Ncgc00094324-02

23. 3-(((dimethylamino)carbonyl)oxy)-1-methylpyridinium Bromide

24. Smr000058605

25. Ro-1-5130

26. 3-(dimethylcarbamyloxy)-1-methylpyridinium Bromide

27. Dsstox_cid_3540

28. 1-methyl-3-hydroxypyridinium Bromide Dimethylcarbamate

29. Dsstox_rid_77069

30. Dsstox_gsid_23540

31. Dimethylcarbamic Acid Ester Of 3-hydroxy-1-methylpyridinium Bromide

32. Chembl812

33. Carbamic Acid, Dimethyl-, Ester With 3-hydroxy-1-methylpyridinium Bromide

34. Unii-19qm69hh21

35. 3-dimethylcarbamoyloxy-1-methylpyridinium Bromide;3-dimethylcarbamoyloxy-1-methylpyridinium Bromide

36. Cas-101-26-8

37. Piridostigmina Bromuro [dcit]

38. Ccris 6798

39. Piridostigmina Bromuro

40. Hsdb 3924

41. Sr-01000003072

42. Bromure De Pyridostigmine

43. Bromuro De Piridostigmina

44. Einecs 202-929-9

45. Pyridostigmini Bromidum [inn-latin]

46. Bromure De Pyridostigmine [inn-french]

47. 3-{[(dimethylamino)carbonyl]oxy}-1-methylpyridinium Bromide

48. Unii-kvi301na53

49. Bromuro De Piridostigmina [inn-spanish]

50. Mestinon-sr

51. Pyridinium, 3-[[(dimethylamino)carbonyl]oxy]-1-methyl-, Bromide (1:1)

52. Pyridinium, 3-(((dimethylamino)carbonyl)oxy)-1-methyl-, Bromide (1:1)

53. Mestinon (tn)

54. Pyridostigminebromine

55. Mfcd00079283

56. Pyridinium, 3-hydroxyl-1-methyl-, Bromide, Dimethylcarbamate

57. Opera_id_420

58. 3-hydroxy-1-methylpyridinium Bromide Dimethylcarbamate (ester)

59. Pyridostigmine Bromide [usp:inn:ban:jan]

60. Schembl41147

61. Mls001074080

62. Spectrum1503240

63. Chebi:8666

64. 3-(dimethylaminocarbonyloxy)-1-methylpyridinium Bromide

65. Dtxsid9023540

66. Hms500k09

67. Hy-b0207a

68. Pyridostigmine Bromide (mestinon)

69. Hms1922m05

70. Hms2092p14

71. Hms2234d06

72. Hms3259m16

73. Hms3263o11

74. Hms3369p02

75. Hms3651g13

76. Hms3884m21

77. Pharmakon1600-01503240

78. Pyridostigmine Bromide [mi]

79. Bcp02148

80. Pyridostigmine Bromide [inn]

81. Pyridostigmine Bromide [jan]

82. Tox21_111266

83. Tox21_501035

84. Ccg-40306

85. Nsc679759

86. Nsc758435

87. Pyridinium, 3-hydroxy-1-methyl-, Bromide, Dimethylcarbamate (ester)

88. Pyridostigmine Bromide [hsdb]

89. S1608

90. Akos015895321

91. Pyridostigmine Bromide [mart.]

92. Tox21_111266_1

93. Ac-8143

94. Lp01035

95. Nc00581

96. Nsc 758435

97. Pyridostigmine Bromide [usp-rs]

98. Pyridostigmine Bromide [who-dd]

99. Pyridostigmine Bromide [who-ip]

100. Ncgc00015862-07

101. Ncgc00094324-01

102. Ncgc00094324-03

103. Ncgc00094324-04

104. Ncgc00261720-01

105. Pyridostigmine Bromide (jp17/usp/inn)

106. As-13164

107. Pyridostigmine Bromide [ep Impurity]

108. Pyridostigmine Bromide [orange Book]

109. Eu-0101035

110. Ft-0603307

111. P1339

112. Pyridostigmine Bromide [ep Monograph]

113. Sw199029-2

114. Pyridostigmine Bromide [usp Monograph]

115. Pyridostigmini Bromidum [who-ip Latin]

116. D00487

117. P 9797

118. T71526

119. Q-201644

120. Sr-01000003072-2

121. Sr-01000003072-4

122. Q26840825

123. 3-((dimethylcarbamoyl)oxy)-1-methylpyridin-1-iumbromide

124. Z1541632810

125. Pyridostigmine Bromide, European Pharmacopoeia (ep) Reference Standard

126. Pyridostigmine Bromide, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₃BrN₂O₂
Molecular Weight	261.12 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	2
Exact Mass	260.01604 g/mol
Monoisotopic Mass	260.01604 g/mol
Topological Polar Surface Area	33.4 Å²
Heavy Atom Count	14
Formal Charge	0
Complexity	183
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Mestinon
PubMed Health	Pyridostigmine Bromide (By mouth)
Drug Classes	Central Nervous System Agent, Immunological Agent, Nerve Gas Antidote
Drug Label	Mestinon (pyridostigmine bromide) is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:Mestinon is available in the following forms: Syru...
Active Ingredient	Pyridostigmine bromide
Dosage Form	Tablet, extended release; Tablet; Syrup; Injectable
Route	Injection; Oral
Strength	180mg; 60mg/5ml; 5mg/ml; 60mg
Market Status	Prescription
Company	Valeant Pharm North; Valeant Pharm Intl; Valeant Pharms

2 of 4
Drug Name	Pyridostigmine bromide
PubMed Health	Pyridostigmine Bromide (By mouth)
Drug Classes	Central Nervous System Agent, Immunological Agent, Nerve Gas Antidote
Drug Label	Pyridostigmine bromide is an orally active, reversible cholinesterase inhibitor. Its chemical name is: 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate.CAS registration number is 101-26-8.Pyridostigmine bromide has a molecular formula of C9H13B...
Active Ingredient	Pyridostigmine bromide
Dosage Form	Tablet
Route	Oral
Strength	60mg
Market Status	Prescription
Company	Impax Labs

3 of 4
Drug Name	Mestinon
PubMed Health	Pyridostigmine Bromide (By mouth)
Drug Classes	Central Nervous System Agent, Immunological Agent, Nerve Gas Antidote
Drug Label	Mestinon (pyridostigmine bromide) is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:Mestinon is available in the following forms: Syru...
Active Ingredient	Pyridostigmine bromide
Dosage Form	Tablet, extended release; Tablet; Syrup; Injectable
Route	Injection; Oral
Strength	180mg; 60mg/5ml; 5mg/ml; 60mg
Market Status	Prescription
Company	Valeant Pharm North; Valeant Pharm Intl; Valeant Pharms

4 of 4
Drug Name	Pyridostigmine bromide
PubMed Health	Pyridostigmine Bromide (By mouth)
Drug Classes	Central Nervous System Agent, Immunological Agent, Nerve Gas Antidote
Drug Label	Pyridostigmine bromide is an orally active, reversible cholinesterase inhibitor. Its chemical name is: 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate.CAS registration number is 101-26-8.Pyridostigmine bromide has a molecular formula of C9H13B...
Active Ingredient	Pyridostigmine bromide
Dosage Form	Tablet
Route	Oral
Strength	60mg
Market Status	Prescription
Company	Impax Labs

4.2 Therapeutic Uses

Cholinesterase Inhibitors; Parasympathomimetics

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

A QUATERNARY AMMONIUM ANTICHOLINESTERASE DRUG ...PRINCIPAL USE IS IN THE TREATMENT OF MYASTHENIA GRAVIS. ...

Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 842

DOSAGE: THE EQUIVALENT PARENTERAL DOSE OF...PYRIDOSTIGMINE IS APPROX 1/30TH OF THE ORAL DOSE.

Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 1029

PYRIDOSTIGMINE HAS A SLOWER ONSET (13 MIN) THAN EDROPHONIUM (3 MIN) OR NEOSTIGMINE (6-8 MIN), BUT A LONGER DURATION OF ACTION THAN EITHER. FOR THIS REASON, IT HAS BEEN RECOMMENDED FOR PATIENTS WITH RENAL IMPAIRMENT.

American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 5th ed. Chicago: American Medical Association, 1983., p. 424

For more Therapeutic Uses (Complete) data for PYRIDOSTIGMINE BROMIDE (9 total), please visit the HSDB record page.

4.3 Drug Warning

BROMIDE SENSITIVITY OCCASIONALLY OCCURS.

Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 842

Maternal Medication usually Compatible with Breast-Feeding: Pyridostigmine: Reported Sign or Symptom in Infant or Effect on Lactation: None. /from Table 6/

Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 141 (1994)

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Cholinesterase Inhibitors

Drugs that inhibit cholinesterases. The neurotransmitter ACETYLCHOLINE is rapidly hydrolyzed, and thereby inactivated, by cholinesterases. When cholinesterases are inhibited, the action of endogenously released acetylcholine at cholinergic synapses is potentiated. Cholinesterase inhibitors are widely used clinically for their potentiation of cholinergic inputs to the gastrointestinal tract and urinary bladder, the eye, and skeletal muscles; they are also used for their effects on the heart and the central nervous system. (See all compounds classified as Cholinesterase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cholinesterase Inhibitors [MoA]; Cholinesterase Inhibitor [EPC]

5.3 Absorption, Distribution and Excretion

ITS ONSET OF ACTION BY ORAL ROUTE IS ABOUT 320 MIN...ITS DURATION OF ACTION BY THE ORAL ROUTE IS USUALLY SOMEWHAT LONGER AND ABSORPTION IS LESS ERRATIC THAN NEOSTIGMINE, WHICH ARE ADVANTAGES.

Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 842

Plasma concn of pyridostigmine was determined in 2 nursing mothers who were receiving oral doses of pyridostigmine bromide, 120-300 mg daily. The drug was not detectable in infant plasma and there were no signs of drug effects in the infant.

Hardell LI et al; Pyridostigmine in human breast milk; Br J Clin Pharmacol 14 (Oct): 565-7 (1982)

5.4 Metabolism/Metabolites

PYRIDOSTIGMINE AND ITS QUATERNARY ALCOHOL ARE...THE PREDOMINANT ENTITIES FOUND IN URINE AFTER ADMIN OF THIS DRUG TO MAN.

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. 108

5.5 Biological Half-Life

After admin of pyridostigmine bromide (200 nmol/kg, iv) to human subjects, the disposition half-life was 0.6-1.78 min and terminal half-life was 14.81-37.01 min. Clearance was 9.3-26.5 ml/min/kg which was greater than the presumptive value for glomerular filtration rate and the vol of distribution was 246.5-833.9 ml/kg.

Calvey TN et al; Kinetics of intravenous pyridostigmine in man; Br J Clin Pharmacol 11 (4): 406-8 (1981)

5.6 Mechanism of Action

...PHARMACOLOGICAL EFFECTS OF ANTICHOLINESTERASE AGENTS ARE DUE PRIMARILY TO PREVENTION OF HYDROLYSIS OF /ACH/ ACETYLCHOLINE BY ACHE /ACETYLCHOLINESTERASE/ @ SITES OF CHOLINERGIC TRANSMISSION. TRANSMITTER THUS ACCUMULATES, AND THE ACTION OF ACH /ACETYLCHOLINE/ THAT IS LIBERATED BY CHOLINERGIC IMPULSES OR THAT LEAKS FROM THE NERVE ENDING IS ENHANCED.

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. 103

Following admin of pyridostigmine bromide to rats, erythrocyte acetylcholinesterase activity recovered only slowly due to the covalent nature of inhibition. The logarithm of the plasma concn of pyridostigmine bromide was linearly related to the increase in tibialis twitch tension due to facilitation of neuromuscular transmission.

Barber HE et al; The relationship between the pharmacokinetics, cholinesterase inhibition and facilitation of twitch tension of the quaternary ammonium anticholinesterase drugs, neostigmine, pyridostigmine, edrophonium and 3-hydroxyphenyltrimethylammonium; Br J Pharmacol 66 (4): 525-30 (1979)

Of 12 analogs of pyridostigmine prepared by reacting 2-substituted 3-pyridinols with the desired carbamoyl chloride 2-iodo-3-(dimethylcarbamoyloxy)pyridine methiodide was the most active inhibitor of acetylcholinesterase and butyrylcholinesterase. The progressive inhibition curves for AChE and BuChE are compared and related to ionic attraction and steric requirements of the inhibitors.

Millner OE Jr et al; Synthesis and enzymic evaluation of pyridostigmine analogs used to probe the active sites of acetylcholinesterase and butyrylcholinesterase; J Med Chem 17 (1): 13-8 (1974)

API SUPPLIERS

01

Minakem (formerly Delmar Chemicals...

Canada

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Minakem is manufacturing small molecules APIs including corticosteroids

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Seqens

France

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Procos

Italy

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Not Confirmed

04

SHANGHAI ZHONGXI SUNVE PHARMACEUTI...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Maithri Drugs

India

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06

Royal DSM

Netherlands

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07

Global Calcium

India

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Bausch Health

Canada

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Unichem Laboratories Limited

India

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F. Hoffmann-La Roche

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API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"255.00","actualQuantity":"255","unit":"KGS","unitRateFc":"420","totalValueFC":"108257.2","currency":"USD","unitRateINR":"35826","date":"18-Nov-2024","totalValueINR":"9135630","totalValueInUsd":"108257.2","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"6735923","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA MATTEOTTI, 249 28062 CAMERI NO ITALY Cameri, , Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"}]

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

Pyridostigmine Bromide Manufacturers

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

Pyridostigmine Bromide Suppliers

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

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

Pyridostigmine Bromide USDMF

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

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

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

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

Pyridostigmine Bromide KDMF

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

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

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

click here to find a list of Pyridostigmine Bromide suppliers with KDMF on PharmaCompass.

Pyridostigmine Bromide CEP

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

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

Pyridostigmine Bromide WC

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

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

Pyridostigmine Bromide 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 Pyridostigmine Bromide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pyridostigmine Bromide GMP

Pyridostigmine Bromide 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 Pyridostigmine Bromide 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 Pyridostigmine Bromide GMP manufacturer or Pyridostigmine Bromide GMP API supplier for your needs.

Pyridostigmine Bromide CoA

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

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

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