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Drug Product Composition: Buprenorphine Hydrochloride

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$ API Ref.Price (USD/KG) : 21,460Xls

USFDA APPLICATION NUMBER - 22410 / DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ)
BUPRENORPHINE HYDROCHLORIDE2mg
NALOXONE HYDROCHLORIDE(UNII: F850569PQR)
(NALOXONE - UNII:36B82AMQ7N)
NALOXONE HYDROCHLORIDE0.5mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Almatica Pharma Inc.
Alvogen Inc.
Apotex Corp.
Bryant Ranch Prepack
Dr.Reddys Laboratories Inc
Indivior Inc.
Mylan Pharmaceuticals Inc.
Quality Care Products, LLC
acesulfame potassium(23OV73Q5G9)
ALCOHOL(3K9958V90M)       
AMMONIA(5138Q19F1X)     
ANHYDROUS CITRIC ACID(XF417D3PSL)      
BUTYL ALCOHOL(8PJ61P6TS3)       
BUTYLATED HYDROXYANISOLE(REK4960K2U)       
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)        
CITRIC ACID MONOHYDRATE(2968PHW8QP)   
FD&C BLUE NO. 1(H3R47K3TBD)       
FD&C YELLOW NO. 6(H77VEI93A8)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)        
HYPROMELLOSES(3NXW29V3WO)     
ISOPROPYL ALCOHOL(ND2M416302)       
maltitol(D65DG142WK)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)      
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)       
POLYETHYLENE OXIDE 100000(V46Y6OJ5QB)       
POLYETHYLENE OXIDE 1000000(HZ58M6D839)        
POLYETHYLENE OXIDE 200000(11628IH70O)      
POLYETHYLENE OXIDE 2000000(5K3991GVWI)        
POLYETHYLENE OXIDE 900000(16P9295IIL)     
POTASSIUM HYDROXIDE(WZH3C48M4T)       
POVIDONE K29/32(390RMW2PEQ)        
POVIDONE K30(U725QWY32X)       
PROPYLENE GLYCOL(6DC9Q167V3)       
SHELLAC(46N107B71O)       
sodium citrate(1Q73Q2JULR)     
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)        
SODIUM METABISULFITE(4VON5FNS3C)        
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)        
TITANIUM DIOXIDE(15FIX9V2JP)      
TRISODIUM CITRATE DIHYDRATE(B22547B95K)