Geralgine-P

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ACTIVE PHARMA INGREDIENTS

257 API Suppliers, 80 USDMF, 20 CEP/COS, 17 JDMF, 9 EU WC, 108 KDMF, 106 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

158 Drugs in Development

158 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3078 FDF Dossiers, 734 FDA Orange Book, 884 Europe, 307 Canada, 72 Australia, 410 South Africa, 671 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 1 Evonik, 13 Rochem International Inc, 32 SPI Pharma, 37 DKSH, 2 Pharm-RX Chemical, 14 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 21 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 14 Kirsch Pharma, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 CD Formulation, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 4 Finar, 17 Gangwal Chemicals, 2 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

127 Fillers, Diluents & Binders, 92 Thickeners and Stabilizers, 73 Solubilizers, 64 Coating Systems & Additives, 60 Taste Masking, 59 Topical, 55 Direct Compression, 54 Parenteral, 50 Disintegrants & Superdisintegrants, 45 Granulation, 39 Lubricants & Glidants, 38 Film Formers & Plasticizers, 35 Controlled & Modified Release, 28 Emulsifying Agents, 28 Chewable & Orodispersible Aids, 24 Rheology Modifiers, 18 Co-Processed Excipients, 17 Surfactant & Foaming Agents, 12 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 365 News #PharmaBuzz

GLOBAL SALES INFORMATION

94 US Medicaid Prescriptions, 144 Regulatory FDF Prices, 21 Annual Reports

MARKET PLACE

191 APIs, 95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 2 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 JP, 36 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

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USFDA APPLICATION NUMBER - 87003 / DOSAGE - TABLET;ORAL - 325MG;5MG **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
ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325mg
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)	OXYCODONE HYDROCHLORIDE	5mg

Inactive Ingredients

Ingredient Name	West-Ward Pharmaceuticals Corp.
CROSCARMELLOSE SODIUM(M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
SILICON DIOXIDE(ETJ7Z6XBU4)
STEARIC ACID(4ELV7Z65AP)

Setid 3132ab0a 53ee 4f46 Ad5f 2e4af77bc54c Applno 87003 Form Tablet Oral Dosage 325mg 5mg - Drug Product Composition: Geralgine-P

Geralgine-P

Geralgine-P

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

257 API Suppliers

80 USDMF

20 CEP/COS

17 JDMF

9 EU WC

108 KDMF

106 NDC API

34 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

158 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3078 FDF Dossiers

734 FDA Orange Book

884 Europe

307 Canada

72 Australia

410 South Africa

671 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG

SUPPOSITORY;RECTAL - 325MG

SUPPOSITORY;RECTAL - 650MG

SUPPOSITORY;RECTAL - 80MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG;250MG;65MG

TABLET;ORAL - 325MG;37.5MG

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG;15MG

TABLET;ORAL - 300MG;30MG

TABLET;ORAL - 300MG;60MG

TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Minakem

1 Evonik

13 Rochem International Inc

32 SPI Pharma

37 DKSH

2 Pharm-RX Chemical

14 Boai NKY Pharmaceuticals Ltd

11 Gangwal Healthcare

21 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

14 Kirsch Pharma

4 ACG Worldwide

19 Actylis

3 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

1 Avesta Pharma

44 BASF

8 Beneo

2 Bioplus Life Sciences

6 CD Formulation

6 Clariant

12 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

4 Finar

17 Gangwal Chemicals

2 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

5 Ingredion Pharma Solutions

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons