Pepticum

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ACTIVE PHARMA INGREDIENTS

123 API Suppliers, 42 USDMF, 38 CEP/COS, 8 JDMF, 18 EU WC, 24 KDMF, 33 NDC API, 2 VMF, 57 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1027 FDF Dossiers, 96 FDA Orange Book, 571 Europe, 11 Canada, 123 Australia, 40 South Africa, 186 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 20MG, CAPSULE;ORAL - 20MG;1.1GM, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 7 Evonik, 5 Rochem International Inc, 21 SPI Pharma, 15 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 40 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 2 Esteem Industries, 4 Finar, 13 Gangwal Chemicals, 13 Ideal Cures, 5 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

97 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 48 Controlled & Modified Release, 45 Thickeners and Stabilizers, 45 Disintegrants & Superdisintegrants, 43 Solubilizers, 39 Direct Compression, 36 Granulation, 31 Taste Masking, 29 Topical, 28 Lubricants & Glidants, 24 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 20 Parenteral, 11 Emulsifying Agents, 11 Rheology Modifiers, 9 Empty Capsules, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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84 News #PharmaBuzz

84 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 523 Regulatory FDF Prices, 9 Annual Reports

MARKET PLACE

64 APIs, 71 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

14 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

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ANALYTICAL

3 BioAnalytical Methods, 1 Analytical Methods

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USFDA APPLICATION NUMBER - 21849 / DOSAGE - CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OMEPRAZOLE(UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	40mg \| 20mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1100mg \| 1100mg

Inactive Ingredients

Ingredient Name	Oceanside Pharmaceuticals	Prasco Laboratories
croscarmellose sodium(M28OL1HH48)
sodium stearyl fumarate(7CV7WJK4UI)

Drug Product Composition: Pepticum

Pepticum

Pepticum

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

123 API Suppliers

42 USDMF

38 CEP/COS

8 JDMF

18 EU WC

24 KDMF

33 NDC API

2 VMF

57 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

27 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1027 FDF Dossiers

96 FDA Orange Book

571 Europe

11 Canada

123 Australia

40 South Africa

186 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 325MG;40MG

TABLET, DELAYED RELEASE;ORAL - 81MG;40MG

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 20MG

CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 20MG

CAPSULE;ORAL - 20MG;1.1GM

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

7 Evonik

5 Rochem International Inc

21 SPI Pharma

15 DKSH

2 Pharm-RX Chemical

9 Faran Shimi Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

4 ACG Worldwide

9 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

40 BASF

1 Bioplus Life Sciences

15 Corel Pharma Chem

7 DFE Pharma

3 Doshion Polyscience

2 Esteem Industries

4 Finar

13 Gangwal Chemicals

13 Ideal Cures

5 Ingredion Pharma Solutions

38 Kerry

4 Kima Chemical

6 Lonza Capsugel

19 Microlex e.U

2 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

5 Pharmatrans-Sanaq

CAPSULE, DELAYED REL PELLETS;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons