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4 API Suppliers, 3 USDMF, 1 JDMF, 2 NDC API, 1 Listed Suppliers

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3 USDMF
1 JDMF
2 NDC API
1 Listed Suppliers

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Chemistry

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Also known as: 28797-61-7, Pirenzepinum, Pirenzepina, Pirenzepin, 11-[2-(4-methylpiperazin-1-yl)acetyl]-5h-pyrido[2,3-b][1,4]benzodiazepin-6-one, Pirenzepine (inn)

Molecular Formula

C₁₉H₂₁N₅O₂

Molecular Weight

351.4 g/mol

InChI Key

RMHMFHUVIITRHF-UHFFFAOYSA-N

FDA UNII

3G0285N20N

An antimuscarinic agent that inhibits gastric secretion at lower doses than are required to affect gastrointestinal motility, salivary, central nervous system, cardiovascular, ocular, and urinary function. It promotes the healing of duodenal ulcers and due to its cytoprotective action is beneficial in the prevention of duodenal ulcer recurrence. It also potentiates the effect of other antiulcer agents such as CIMETIDINE and RANITIDINE. It is generally well tolerated by patients.

1 2D Structure

Pirenzepine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

11-[2-(4-methylpiperazin-1-yl)acetyl]-5H-pyrido[2,3-b][1,4]benzodiazepin-6-one

2.1.2 InChI

InChI=1S/C19H21N5O2/c1-22-9-11-23(12-10-22)13-17(25)24-16-7-3-2-5-14(16)19(26)21-15-6-4-8-20-18(15)24/h2-8H,9-13H2,1H3,(H,21,26)

2.1.3 InChI Key

RMHMFHUVIITRHF-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN1CCN(CC1)CC(=O)N2C3=CC=CC=C3C(=O)NC4=C2N=CC=C4

2.2 Other Identifiers

2.2.1 UNII

3G0285N20N

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dihydrochloride, Pirenzepine

2. Gastrotsepin

3. Gastrozepin

4. L-s 519

5. Ls 519

6. Ls-519

7. Ls519

8. Piren Basan

9. Piren-basan

10. Pirenzepin

11. Pirenzepin Ratiopharm

12. Pirenzepin Von Ct

13. Pirenzepin-ratiopharm

14. Pirenzepine Dihydrochloride

15. Pyrenzepine

16. Ulcoprotect

17. Ulgescum

18. Von Ct, Pirenzepin

2.3.2 Depositor-Supplied Synonyms

1. 28797-61-7

2. Pirenzepinum

3. Pirenzepina

4. Pirenzepin

5. 11-[2-(4-methylpiperazin-1-yl)acetyl]-5h-pyrido[2,3-b][1,4]benzodiazepin-6-one

6. Pirenzepine (inn)

7. 11-((4-methyl-1-piperazinyl)acetyl)-5,11-dihydro-6h-pyrido(2,3-b)(1,4)benzodiazepin-6-one

8. 11-[(4-methylpiperazin-1-yl)acetyl]-5,11-dihydro-6h-pyrido[2,3-b][1,4]benzodiazepin-6-one

9. Chembl9967

10. 5,11-dihydro-11-((4-methyl-1-piperazinyl)acetyl)-6h-pyrido(2,3-b)(1,4)benzodiazepin-6-one

11. 6h-pyrido(2,3-b)(1,4)benzodiazepin-6-one, 5,11-dihydro-11-((4-methyl-1-piperazinyl)acetyl)-

12. Aci-91

13. Chebi:8247

14. Pirenzepinedihydrochloridemonohydrate

15. 3g0285n20n

16. Ncgc00015836-08

17. Pirenzepinum [inn-latin]

18. Pirenzepina [inn-spanish]

19. Pirenzepine [inn]

20. Dsstox_cid_3487

21. Pirenzepine [inn:ban]

22. Dsstox_rid_77049

23. Dsstox_gsid_23487

24. Mls000069702

25. 5,11-dihydro-11-[(4-methyl-1-piperazinyl)acetyl]-6h-pyrido[2,3-b][1,4]benzodiazepin-6-one

26. 6h-pyrido[2,3-b][1,4]benzodiazepin-6-one, 5,11-dihydro-11-[(4-methyl-1-piperazinyl)acetyl]-

27. 6h-pyrido[2,3-b][1,4]benzodiazepin-6-one, 5,11-dihydro-11-[(4-methyl-1-piperazinyl)acetyl]- (8ci,9ci)

28. 6h-pyrido[2,3-b][1,4]benzodiazepin-6-one, 5,11-dihydro-11-[2-(4-methyl-1-piperazinyl)acetyl]-

29. Cas-28797-61-7

30. Smr000058502

31. Einecs 249-228-4

32. Ls-519

33. Brn 0628987

34. Unii-3g0285n20n

35. Pirenzepine-[d8]

36. Spectrum_001378

37. Tocris-1071

38. Starbld0016668

39. Pirenzepine [mi]

40. Prestwick0_000129

41. Prestwick1_000129

42. Prestwick2_000129

43. Prestwick3_000129

44. Spectrum2_001417

45. Spectrum3_001453

46. Spectrum4_000437

47. Spectrum5_001344

48. Lopac-p-7412

49. Pirenzepine [vandf]

50. Lopac0_000962

51. Schembl41705

52. Bspbio_000178

53. Bspbio_002945

54. Gtpl328

55. Kbiogr_000794

56. Kbioss_001858

57. Pirenzepine [who-dd]

58. Divk1c_000127

59. Spbio_001494

60. Spbio_002117

61. Bpbio1_000196

62. Cid_185248

63. Dtxsid7023487

64. Bdbm39341

65. Kbio1_000127

66. Kbio2_001858

67. Kbio2_004426

68. Kbio2_006994

69. Kbio3_002445

70. Ninds_000127

71. Hms2089k21

72. Hms3742e07

73. Hms3742g13

74. Bcp12188

75. Tox21_110239

76. Hy-17037a

77. Pdsp1_000965

78. Pdsp2_000949

79. Zinc19632927

80. Akos015969751

81. Tox21_110239_1

82. Ccg-205042

83. Db00670

84. Sdccgsbi-0050935.p004

85. Idi1_000127

86. Ncgc00015836-01

87. Ncgc00015836-02

88. Ncgc00015836-03

89. Ncgc00015836-04

90. Ncgc00015836-05

91. Ncgc00015836-06

92. Ncgc00015836-07

93. Ncgc00015836-09

94. Ncgc00015836-10

95. Ncgc00015836-12

96. Ncgc00015836-19

97. Ncgc00024297-02

98. Ncgc00024297-04

99. Ncgc00024297-05

100. Sbi-0050935.p003

101. Cas-29868-97-1

102. Ab00053603

103. Cs-0013749

104. Ft-0600051

105. Ft-0673943

106. 97p617

107. C07508

108. D08389

109. Ab00053603-08

110. Ab00053603_09

111. L000485

112. Q419550

113. Brd-k89375097-300-05-4

114. Brd-k89375097-300-06-2

115. 11-[2-(4-methylpiperazino)acetyl]-5h-pyrido[2,3-b][1,4]benzodiazepin-6-one;hydrochloride

116. 11-[(4-methyl-1-piperazinyl)acetyl]-5,11-dihydro-6h-pyrido[2,3-b][1,4]benzodiazepin-6-one #

117. 11-[2-(4-methyl-1-piperazinyl)-1-oxoethyl]-5h-pyrido[2,3-b][1,4]benzodiazepin-6-one;hydrochloride

118. 11-[2-(4-methyl-piperazin-1-yl)-acetyl]-5,11-dihydro-benzo[e]pyrido[3,2-b][1,4]diazepin-6-one

119. 11-[2-(4-methylpiperazin-1-yl)-acetyl]-5,11-dihydro-6h-pyrido[2,3-b][1,4]benzodiazepin-6-one

120. 11-[2-(4-methylpiperazin-1-yl)acetyl]-5h-pyrido[2,3-b][1,4]benzodiazepin-6-one;hydrochloride

121. 11-[2-(4-methylpiperazin-1-yl)ethanoyl]-5h-pyrido[2,3-b][1,4]benzodiazepin-6-one;hydrochloride

122. 2-[2-(4-methylpiperazin-1-yl)acetyl]-2,4,9-triazatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,12,14-hexaen-10-one

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₁N₅O₂
Molecular Weight	351.4 g/mol
XLogP3	0.1
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	351.16952493 g/mol
Monoisotopic Mass	351.16952493 g/mol
Topological Polar Surface Area	68.8 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	534
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	1

4 Drug and Medication Information

4.1 Drug Indication

For the treatment of peptic ulcer, gastric ulcer, and duodenal ulcer.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Pirenzepine belongs to a group of medications called antispasmodics/anticholinergics. These medications are used to relieve cramps or spasms of the stomach, intestines, and bladder. Pirenzepine is used to treat duodenal or stomach ulcers or intestine problems. It can be used together with antacids or other medicine in the treatment of peptic ulcer. It may also be used to prevent nausea, vomiting, and motion sickness.

5.2 MeSH Pharmacological Classification

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

5.3 ATC Code

A - Alimentary tract and metabolism

A02 - Drugs for acid related disorders

A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

A02BX - Other drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

A02BX03 - Pirenzepine

5.4 Mechanism of Action

Pirenzepine is a muscarinic receptor antagonist and binds to the muscarinic acetylcholine receptor. The muscarinic acetylcholine receptor mediates various cellular responses, including inhibition of adenylate cyclase, breakdown of phosphoinositides and modulation of potassium channels through the action of G proteins.

API SUPPLIERS

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USDMF

01

Archimica Spa

Italy

Medlab Asia & Asia Health

Not Confirmed

02

Archimica Spa

Italy

Medlab Asia & Asia Health

Not Confirmed

03

Prosintex Industrie Chimique Italian...

Country

Medlab Asia & Asia Health

Not Confirmed

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JDMF

01

Daiwa Pharmaceutical Industries Co....

Japan

Medlab Asia & Asia Health

Not Confirmed

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NDC API

01

Excella GmbH & Co. KG

Luxembourg

Medlab Asia & Asia Health

Not Confirmed

Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

Contact Supplier

Luxembourg

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PIRENZEPINE

NDC Package Code : 46014-1210

Start Marketing Date : 2022-04-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product Web Link

02

Archimica S.p.A.

Italy

Medlab Asia & Asia Health

Not Confirmed

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Listed Suppliers

01

Archimica

Italy

Medlab Asia & Asia Health

Not Confirmed

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DATA COMPILATION #PharmaFlow

DMF submissions in 2019: India maintains bulk drug supply supremacy to US

At PharmaCompass, we highlighted the significance of India in the global active pharmaceutical ingredient (API) supply chain last week with our list of generic drug facilities registered with the US Food and Drug Administration (FDA). Our compilation revealed that India had 182 generic drug facilities registered with the FDA and this number was nearly as much as the corresponding numbers for China (100) and United States (84) put together. These 182 facilities paid a fee of US$ 59,400 each to the FDA. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) This week, we review the API Drug Master Files (DMFs) submitted to the FDA in 2019. Expectedly, India also led the DMF submission list. In 2019, there were 616 active DMF submissions to the FDA with Indian companies submitting more than half (331) of them. Submissions from India were a little less than double the number of DMF submissions made by Chinese (113) and the US (57) firms put together. Drug master files (DMFs) are submissions made to the FDA by manufacturers by providing the agency with confidential, detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of human drug products. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) MSN Labs leads total count of DMF filings The 616 active DMF filings to the FDA were quite diverse — they covered over 400 products, and over half (322) the filings were for unique products. Among the products with multiple DMF filings, Sugammadex Sodium topped the list as it had 18 DMF filings. Sugammadex is the API used in Merck’s Bridion for the reversal of neuromuscular blockade induced by rocuronium and vecuronium in general anesthesia. The other products with over five DMF filings were for the APIs of Lundbeck and Otsuka’s antipsychotic drug Brexpiprazole, Novartis, Gilead and Intercept’s blockbuster products Sacubitril-Valsartan, Tenofovir Alafenamide Fumarate and Obeticholic Acid. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) The year 2019 also witnessed continued DMF filings for Rivaroxaban, Sitagliptin Phosphate, Ticagrelor and Tipiracil Hydrochloride. These filings indicate that the companies currently developing these products should brace themselves for intense competition in the near future. India’s MSN Labs continued to lead the count of total DMF filings with 42, of which it had 17 filings where it was the only one submitting a DMF for a specific product in 2019. The leading Chinese company filing DMFs was Fuxin Long Rui Pharmaceutical with nine DMFs, followed by Brightgene Bio-Medical Technology Co with five. The API DMF is part of the final generic drug product submission to the FDA. Therefore, the owner of a DMF incurs a one-time fee (US$ 55,013 for FY2019, US$ 57, 795 for FY2020) the first time the generic drug submission references that DMF. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) DMF holders may also pay the fee in advance in order to have their DMF subjected to an initial completeness assessment by the FDA. This would allow their DMF to be included on a publicly-available list of DMFs that have paid their fee and not failed the initial completeness assessment. Aurobindo, Sun, Lupin lead DMF assessments While reviewing the DMF submissions made in 2019, we found that a third (209 out of 621) of the DMFs were listed on FDA’s publicly-available list of DMFs that have paid their fee and whose initial assessment had been completed. This indicates that either companies may have been unwilling to pay the fee or the FDA’s review process found shortcomings in their applications. Major Indian generic drug companies like Aurobindo (16), Sun Pharmaceuticals (13), MSN Labs (12), Lupin (7) and Macleods (7) led the list of companies that had the maximum DMF assessments completed for their 2019 submissions. There are also DMF submissions for products which can sometimes indicate future drug approvals. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) Sanyo Chemicals submitted a DMF for Ibudilast, an anti-inflammatory drug whose oral capsules are used in Japan for the treatment of asthma and its ophthalmic solution is used to treat allergic conjunctivitis. The product is currently not approved in the United States. New drug approvals in the future can also be expected for Tertomotide, Omarigliptin, Estetrol Monohydrate, Abametapir, Pirenzepine, Cortexolone Proprionate, Lurbinectedin, Terlipressin, Ethyl Olivetolate, Remimazolam and Triapine. These products are currently under clinical trials for a variety of indications. Our view After compiling the list of companies that have submitted DMFs to the FDA as well as the generic facilities that paid their user fees, it’s clear that the API industry is beginning to find a new equilibrium. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) Our compilations of the previous years have shown that there is a steady decline in facility registrations and DMF filings. Given the increasing costs involved, as well as scaled up regulatory requirements, it seems that companies are becoming more selective in their product development decisions and also their willingness to do business in the United States. While the number of Indian API facilities registered with the FDA has remained relatively unchanged, the number of Chinese sites that registered with the US has reduced by 35 percent over the past five years. Several factors are changing the landscape of the generic drug industry. For instance, environmental regulations in China are driving up the cost of raw materials. Quality issues — such as the valsartan impurities case — have increased regulatory scrutiny. Moreover, passing inspections continues to remain a challenge for many manufacturers. And generic drug product manufacturers are also facing margin pressures, which in turn is driving a lot of M&A activity. Given this scenario, the generic industry should brace itself for more challenges in 2020. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)