Methylphenidate Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 20 USDMF, 16 CEP/COS, 1 JDMF, 4 EU WC, 8 KDMF, 20 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

FINISHED DOSAGE FORMULATIONS

411 FDF Dossiers, 262 FDA Orange Book, 111 Europe, 7 Canada, 31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 18MG, TABLET, EXTENDED RELEASE;ORAL - 27MG, TABLET, EXTENDED RELEASE;ORAL - 36MG, TABLET, EXTENDED RELEASE;ORAL - 54MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, SOLUTION;ORAL - 10MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 6 Evonik, 8 Rochem International Inc, 20 SPI Pharma, 21 DKSH, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 8 Kirsch Pharma, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 38 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 20 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 2 Hayashibara, 13 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 36 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 6 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 81 Coating Systems & Additives, 56 Thickeners and Stabilizers, 49 Controlled & Modified Release, 40 Direct Compression, 39 Taste Masking, 35 Granulation, 34 Solubilizers, 30 Topical, 30 Film Formers & Plasticizers, 29 Parenteral, 27 Disintegrants & Superdisintegrants, 26 Lubricants & Glidants, 24 Chewable & Orodispersible Aids, 12 Co-Processed Excipients, 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

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 70 News #PharmaBuzz

GLOBAL SALES INFORMATION

47 US Medicaid Prescriptions, 89 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

224 US Patents, 57 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 202100 / DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)	METHYLPHENIDATE HYDROCHLORIDE	750mg in 150 \| 900mg in 180 \| 600mg in 120 \| 300mg in 60

Inactive Ingredients

Ingredient Name	NextWave Pharmaceuticals, Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)
POLOXAMER 188(LQA7B6G8JG)
POLYVINYL ACETATE PHTHALATE(58QVG85GW3)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM POLYSTYRENE SULFONATE(1699G8679Z)
STARCH, CORN(O8232NY3SJ)
SUCRALOSE(96K6UQ3ZD4)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TRIACETIN(XHX3C3X673)
XANTHAN GUM(TTV12P4NEE)

Setid E0157005 6e3e 4763 B910 9eb0937608c9 Applno 202100 Form For Suspension Extended Release Oral Dosage 5mg Ml - Drug Product Composition: Methylphenidate Hydrochloride