Anhydrous Citric Acid

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ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 2 USDMF, 1 CEP/COS, 4 JDMF, 2 NDC API, 6 Listed Suppliers, $ API Reference Price

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40 Drugs in Development

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82 FDF Dossiers, 9 FDA Orange Book, 15 Europe, 49 Canada, 7 South Africa, 2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;IRRIGATION - 6.602GM/100ML;198MG/100ML;3.177GM/100ML, FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT

RELATED EXCIPIENT COMPANIES

10 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 10 DKSH, 2 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 22 BASF, 1 Bioplus Life Sciences, 2 Clariant, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 14 Finished Drug Prices

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28 APIs, 1 FDF Dossiers, 13 EXCIPIENTS, 1 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 4 USP, 1 Others

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USFDA APPLICATION NUMBER - 19481 / DOSAGE - SOLUTION;IRRIGATION - 6.602GM/100ML;198MG/100ML;3.177GM/100ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	6.6g in 100
GLUCONOLACTONE(UNII: WQ29KQ9POT) (GLUCONOLACTONE - UNII:WQ29KQ9POT)	GLUCONOLACTONE	0.198g in 100
MAGNESIUM CARBONATE(UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	3.376g in 100

Inactive Ingredients

Ingredient Name	United-Guardian, Inc.
BENZOIC ACID(8SKN0B0MIM)

Drug Product Composition: Anhydrous Citric Acid