Zydus Pharmaceuticals, Inc. (“Zydus”) Has Recalculated .
Notice Regarding Recalculated 340B Ceiling Prices for Zydus Pharmaceuticals, Inc. Products Impactedfor the Time Period 1Q 2012 through 4Q 2014Zydus Pharmaceuticals, Inc. (“Zydus”) has recalculated Average Manufacturer Price (“AMP”) and BestPrice (“BP”) values previously submitted to the Centers for Medicare & Medicaid Services (“CMS”) forcertain products for the 3Q 2011 through 2Q 2014 time period. Zydus has also recalculated the 340Bceiling prices for the products on the attached list and associated quarters of 1Q 2012 through 4Q 2014based on the corrected AMP and BP values.Zydus has asked the Office of Pharmacy Affairs “(OPA”) to post this notice on OPA’s public website toensure transparency by providing access to information regarding Zydus’ recalculation and potentialoverpayment by certain 340B Covered Entities for impacted Zydus products related thereto. Zydus willbe communicating with and issuing refunds via Apexus to 340B Covered Entities where the Zydus datademonstrates that a 340B Covered Entity has overpaid by 10 or more in the aggregate for theimpacted products set forth above for the 1Q 2012 through 4Q 2014 time period.In the event the Zydus data demonstrates that a 340B Covered Entity has overpaid less than 10 in theaggregate for the impacted products set forth above for the 1Q 2012 through 4Q 2014 time period,Zydus will not be issuing refunds on its own accord. However, if any 340B Covered Entity believes it hasoverpaid by 10 or less in the aggregate for the impacted products set forth above for the 1Q 2012through 4Q 2014 time period and would like a refund, the Covered Entity should contact Zydus directlyat 609-730-1900 or via email at 340BRefund@zydususa.com. Please give Apexus sufficient time tocontact impacted 340B Covered Entities prior to contacting Zydus. If you have not been contacted byApexus by November 30th 2015, then you can assume your organization is not above the 10 impactlevel and may contact Zydus for a refund.Upon the 340B Covered Entity’s request, and upon our internal validation, an aggregate overpaymentless than 10 by a 340B Covered Entity for the impacted products set forth in the attached list for the 1Q2012 through 4Q 2014 time period will be refunded by Zydus so long as such request is received on orbefore December 31, 2015.
Impacted 30016838200300568382003010Product DescriptionPotassium Chloride ER Cap 10 mEq (500Ct)Potassium Chloride ER Cap 10 mEq (100Ct)Potassium Chloride ER Cap 8 mEq (100Ct)Paroxetine Tablets 40 mg (500ct)Paroxetine Tablets 40 mg (30ct)Paroxetine Tablets 40 mg (90ct)Azathioprine Tablets 50 mg (100ct)Azathioprine Tablets 50 mg (500ct)Topiramate Sprinkle Caps 15 mg (60Ct)Topiramate Sprinkle Caps 25 mg (60Ct)Lamotrigine Tablets 25 mg (100ct)Lamotrigine Tablets 25 mg (1000ct)Lamotrigine Tablets 100 mg (100ct)Lamotrigine Tablets 100 mg (1000ct)Lamotrigine Tablets 150 mg (500ct)Lamotrigine Tablets 150 mg (60ct)Lamotrigine Tablets 200 mg (500ct)Lamotrigine Tablets 200 mg (60ct)Levofloxacin Tab 250mg (50 Ct)Levofloxacin Tab 500mg (100 Ct)LevofloxacinTab500mg(50Ct)Levofloxacin Tab 750mg (100 Ct)LevofloxacinTab750mg(50Ct)Venlafaxine HCl Tablets 25 mg (100ct)Venlafaxine HCl Tablets 37.5 mg (100ct)Venlafaxine HCl Tablets 50 mg (100ct)Venlafaxine HCl Tablets 75 mg (100ct)Atenolol Tablets 25mg (100ct)Atenolol Tablets 25 mg (1000ct)Atenolol Tablets 50 mg (100ct)Atenolol Tablets 50 mg (1000ct)Atenolol Tablets 100 mg (100ct)Atenolol Tablets 100 mg (1000ct)Metformin Tablets 500 mg (100ct)Metformin Tablets 500 mg (500ct)Metformin Tablets 500 mg (1000ct)Metformin Tablets 850 mg (100ct)Metformin Tablets 850 mg (500ct)Metformin Tablets 850 mg (1000ct)Metformin Tablets 1000 mg (100ct)Metformin Tablets 1000 mg (500ct)Metformin Tablets 1000 mg (1000ct)
proex Sodium DR Tab 125 mg (100ct)Divalproex Sodium DR Tab 250 mg (100ct)Divalproex Sodium DR Tab 250 mg (500ct)Divalproex Sodium DR Tab 500 mg (100ct)Divalproex Sodium DR Tab 500 mg (500ct)Venlafaxine ER Capsules 37.5 mg (30Ct)Venlafaxine ER Capsules 37.5 mg (1000Ct)Venlafaxine ER Capsules 37.5 mg (90Ct)Venlafaxine ER Capsules 75 mg (30Ct)Venlafaxine ER Capsules 75 mg (1000Ct)Venlafaxine ER Capsules 75 mg (90Ct)Venlafaxine ER Capsules 150 mg (30Ct)Venlafaxine ER Capsules 150 mg (1000Ct)Venlafaxine ER Capsules 150 mg (90Ct)Promethazine Tablets 12.5 mg (100ct)Promethazine Tablets 25 mg (100ct)Promethazine Tablets 25 mg (1000ct)Promethazine Tablets 50 mg (100ct)Ribavirin Tablets 200 mg (168ct)Meloxicam Tablets 7.5 mg (100ct)Meloxicam Tablets 7.5 mg (500ct)Meloxicam Tablets 15 mg (100ct)Meloxicam Tablets 15 mg (500ct)Warfarin Tablets 1 mg (100ct)Warfarin Tablets 1 mg (1000ct)Warfarin Tablets 2 mg (100ct)Warfarin Tablets 2 mg (1000ct)Warfarin Tablets 3 mg (100ct)Warfarin Tablets 3 mg (1000ct)Warfarin Tablets 4 mg (100ct)Warfarin Tablets 4 mg (1000ct)Warfarin Tablets 5 mg (100ct)Warfarin Tablets 5 mg (1000ct)Warfarin Na Tab 5mg (90 Ct)Warfarin Tablets 6 mg (100ct)Warfarin Tablets 7.5 mg (100ct)Warfarin Tablets 10 mg (100ct)Warfarin Tablets 2.5 mg (100ct)Warfarin Tablets 2.5 mg (1000ct)Simvastatin Tablets 5 mg (1000ct)Simvastatin Tablets 5 mg (90ct)Simvastatin Tablets 10 mg (500ct)Simvastatin Tablets 10 mg (1000ct)Simvastatin Tablets 10 mg (90ct)Simvastatin Tablets 20 mg (500ct)
statin Tablets 20 mg (1000ct)Simvastatin Tablets 20 mg (90ct)Simvastatin Tablets 40 mg (500ct)Simvastatin Tablets 40 mg (1000ct)Simvastatin Tablets 40 mg (90ct)Simvastatin Tablets 80 mg (500ct)Simvastatin Tablets 80 mg (1000ct)Simvastatin Tablets 80 mg (90ct)Pravastatin Tablets 10 mg (500ct)Pravastatin Tablets 10 mg (90ct)Pravastatin Tablets 20 mg (500ct)Pravastatin Tablets 20 mg (90ct)Pravastatin Tablets 40 mg (500ct)Pravastatin Tablets 40 mg (90ct)Pravastatin Tablets 80 mg (500ct)Pravastatin Tablets 80 mg (90ct)Fenofibric Acid DR Cap 45mg (90 Ct)Fenofibric Acid DR Cap 135mg (90 Ct)Haloperidol Tablets 10 mg (100ct)Haloperidol Tablets 20 mg (100ct)Carvedilol Tablets 3.125 mg (100ct)Carvedilol Tablets 3.125 mg (500ct)Carvedilol Tablets 6.25 mg (100ct)Carvedilol Tablets 6.25 mg (500ct)Carvedilol Tablets 12.5 mg (100ct)Carvedilol Tablets 12.5 mg (500ct)Carvedilol Tablets 25 mg (100ct)Carvedilol Tablets 25 mg (500ct)Hydroxychloroquine Tablet 200 mg (100ct)Hydroxychloroquine Tablet 200 mg (500ct)Paroxetine Tablets 10 mg (500ct)Paroxetine Tablets 10 mg (30ct)Paroxetine Tablets 10 mg (1000ct)Paroxetine Tablets 10 mg (90ct)Paroxetine Tablets 20 mg (100ct)Paroxetine Tablets 20 mg (500ct)Paroxetine Tablets 20 mg (30ct)Paroxetine Tablets 20 mg (1000ct)Paroxetine Tablets 20 mg (90ct)Paroxetine Tablets 30 mg (500ct)Paroxetine Tablets 30 mg (30ct)Paroxetine Tablets 30 mg (1000ct)Paroxetine Tablets 30 mg (90ct)Venlafaxine HCl Tablets 100 mg (100ct)Divalproex Sprinkle Caps 125 mg (100Ct)
proex Sprinkle Caps 125 mg (1000Ct)Lamotrigine CD Tablets 5 mg (100ct)Lamotrigine CD Tablets 25 mg (100ct)Bromocriptine Capsules 5 mg (30Ct)Risperidone Tablets 0.25 mg (500ct)Risperidone Tablets 0.25 mg (60ct)Risperidone Tablets 0.5 mg (500ct)Risperidone Tablets 0.5 mg (60ct)Risperidone Tablets 1 mg (500ct)Risperidone Tablets 1 mg (60ct)Risperidone Tablets 2 mg (500ct)Risperidone Tablets 2 mg (60ct)Risperidone Tablets 3 mg (500ct)Risperidone Tablets 3 mg (60ct)Risperidone Tablets 4 mg (500ct)Risperidone Tablets 4 mg (60ct)Amlodipine Bey. Tablets 2.5 mg (500ct)Amlodipine Bey. Tablets 2.5 mg (90ct)Amlodipine Bey. Tablets 5 mg (500ct)Amlodipine Bey. Tablets 5 mg (90ct)Amlodipine Bey. Tablets 10 mg (500ct)Amlodipine Bey. Tablets 10 mg (90ct)Mycophenolate Mof. Cap 250 mg (100Ct)Mycophenolate Mof. Cap 250 mg (500Ct)Mycophenolate Mof. Tablet 500 mg (100ct)Mycophenolate Mof. Tablet 500 mg (500ct)Tamsulosin HCl Capsules 0.4 mg (100Ct)Tamsulosin HCl Capsules 0.4 mg (1000Ct)Losartan Potassium Tablet 25 mg (30ct)Losartan Potassium Tablet 25 mg (1000ct)Losartan Potassium Tablet 25 mg (90ct)Losartan Potassium Tablet 50 mg (30ct)Losartan Potassium Tablet 50 mg(1000ct)Losartan Potassium Tablet 50 mg (90ct)Losartan Potassium Tablet 100 mg (30ct)Losartan Potassium Tablet 100 mg (1000ct)Losartan Potassium Tablet 100 mg (90ct)TopiramateTablets25mg(500ct)Topiramate Tablets 25 mg (60ct)Topiramate Tab 50mg (500 Ct)Topiramate Tablets 50 mg (60ct)Topiramate Tablets 100 mg (500ct)Topiramate Tablets 100 mg (60ct)Topiramate Tablets 200 mg (500ct)Topiramate Tablets 200 mg (60ct)
66838202301668382024701Losartan Potassium HCTZ 12.5/50mg (30ct)Losartan Potassium HCTZ 12.5/50 mg(100ct)Losartan Potassium HCTZ 12.5/50 mg (90ct)Losartan Potassium HCTZ 25/100 mg (30ct)Losartan Potassium HCTZ 25/100 mg(1000ct)Losartan Potassium HCTZ 25/100 mg (90ct)Ramipril Capsules 1.25 mg (30Ct)Ramipril Capsules 2.5 mg (100Ct)Ramipril Capsules 5 mg (100Ct)Ramipril Capsules 10 mg (100Ct)Risperidone OD Tablets 0.5 mg (30ct)Risperidone OD Tablets 1 mg (30ct)Risperidone OD Tablets 2 mg (30ct)Galantamine HBr Tab 4mg (60 Ct)Galantamine HBr Tab 8mg (60 Ct)Galantamine HBr Tab 12mg (60 Ct)Dipyridamole Tablets 25 mg (100ct)Dipyridamole Tablets 25 mg (500ct)Dipyridamole Tablets 50 mg (100ct)Dipyridamole Tablets 50 mg (500ct)Dipyridamole Tablets 75 mg (100ct)Dipyridamole Tablets 75 mg (500ct)Pramipexole Tablets 0.125mg (90ct)Pramipexole Tablets 0.25mg (90ct)Pramipexole Tablets 0.5mg (90ct)Pramipexole Tablets 1mg (90ct)Pramipexole Tablets 1.5mg (90ct)Niacin ER Tab, 500mg (90 Ct)Niacin ER Tab, 750mg (90 Ct)Niacin ER Tab, 1000mg (90 Ct)Gabapentin Tab 600mg (100 Ct)Gabapentin Tab 600mg (500 Ct)Gabapentin Tab 800mg (100 Ct)Gabapentin Tab 800mg (500 Ct)Anastrozole Tablets 1 mg (30ct)Anastrozole Tablets 1 mg (1000ct)Bicalutamide Tablets 50 mg (100ct)Bicalutamide Tablets 50 mg (30ct)Amiodarone Tablets 200mg (500ct)Amiodarone Tablets 200mg (60ct)Fenofibrate Tab 48mg (90 Ct)Fenofibrate Tab 145mg (90 Ct)Benzonatate Capsules 100 mg (100Ct)
668382050010Benzonatate Capsules 100 mg (500Ct)Benzonatate Capsules 200 mg (100Ct)Ribavirin Capsules 200 mg (42Ct)Ribavirin Capsules 200 mg (56Ct)Ribavirin Capsules 200 mg (70Ct)Ribavirin Capsules 200 mg (84Ct)Acetazolamide ER Capsules 500 mg (100Ct)Paricalcitol Cap 1mcg (30 Ct)Paricalcitol Cap 2mcg (30 Ct)Etodolac ER Tab 400mg (100 Ct)Etodolac ER Tab 400mg (60 Ct)Etodolac ER Tab 500mg (100 Ct)Etodolac ER Tab 600mg (100 00mg(100Ct)Divalproex Na ER Tab 500mg (500 Ct)Tramadol Tablets 50 mg (100ct)Tramadol HCl Tablets 50 mg (1000ct)Tramadol HCl/APAP Tab 37.5/325mg (100Ct)Tramadol HCl/APAP Tab 37.5/325mg (500Ct)Ropinirole HCl Tablets 0.25 mg (100ct)Ropinirole HCl Tablets 1 mg (100ct)Ropinirole HCl Tablets 2 mg (100ct)Ropinirole HCl Tablets 3 mg (100ct)Ropinirole HCl Tablets 4 mg (100ct)Ropinirole HCl Tablets 5 mg (100ct)Donepezil HCL OD Tablets 5 mg (30ct)Donepezil HCL OD Tablets 10 mg (30ct)Bupropion HCl ER Tab 300mg (500 Ct)Potassium Chloride ER Tab 20mEq (100 Ct)Potassium Chloride ER Tab 20mEq (500 Ct)Omeprazole DR Cap 10mg (100 0Ct)Omeprazole DR Cap 20mg (30 Ct)Omeprazole DR Cap 20mg (1000 Ct)Ranitidine HCl Inj 25mg/mL (10x2mL SDvials)Ranitidine HCl Inj 25mg/mL (6mL MD vial)Famotidine For Oral Sus. 40mg (5mL)Omeprazole DR Cap 40mg (100 Ct)OmeprazoleDRCap40mg(30Ct)Omeprazole DR Cap 40mg (1000 Ct)
401683820795016838207960168382079701Sirolimus Tab 0.5mg (100 Ct)Lansoprazole DR Cap 15mg (30 Ct)Lansoprazole DR Cap 15mg (1000 Ct)Lansoprazole DR Cap 30mg (100 Ct)Lansoprazole DR Cap 30mg (30 Ct)Lansoprazole DR Cap 30mg (1000 Ct)Lansoprazole DR Cap 30mg (90 Ct)Potassium Chloride ER Tab 10 mEq (100ct)Potassium Chloride ER Tab 10 mEq (1000ct)PotassiumChlorideERCap10mEq (100Ct)PotassiumChlorideERCap10mEq (500Ct)PotassiumChlorideERCap8mEq (100Ct)ZolmitriptanODTab2.5mg (6Ct)ZolmitriptanODTab5mg (3Ct)ClarithromycinTablets250mg (60ct)ClarithromycinTablets500mg ycin OS 125mg/5mL (50 mL)Clarithromycin OS 125mg/5mL (100 mL)Clarithromycin OS 250mg/5mL (50 mL)Clarithromycin OS 250mg/5mL (100 mL)Oxycodone HCl Tab 5mg (100 Ct)Oxycodone HCl Tab 10mg (100 Ct)Oxycodone HCl Tab 15mg (100 Ct)Oxycodone HCl Tab 20mg (100 Ct)Oxycodone HCl Tab 30mg (100 Ct)
Apexus by November 30th strong 2015 /strong , then you can assume your organization is not above the 10 impact level and strong may /strong contact Zydus for a refund. Upon the 340 overed Entity’s request, and upon our internal validation, an aggregate overpayment . 68382003406 Venlafaxine ER strong Capsules /strong 37.5 mg (30Ct) 68382003410 Venlafaxine ER strong Capsules /strong 37.5 mg (1000Ct)
46783 merz north america, inc. 47335 sun pharmaceuticals industries, inc. 47426 heron therapeutics, inc. . 51525 wallace pharmaceuticals 51645 gemini pharmaceuticals, inc. 51660 ohm pharmaceuticals, inc. . inc. 55670 moore medical 55724 pfizer laboratories div pfizer inc. 57237 rising health, llc. .
In order to ensure the safe and swift provision of pharmaceuticals, medical devices, etc., necessary . Responsibility pertaining to the assurance, etc., of the quality, efficacy and safety of pharmaceuticals etc. is imposed on relevant parties. (3) Marketers of pharmaceuticals etc. are to prepare package inserts based on the latest findings .
10.1 Counterfeit Pharmaceuticals and Medical Devices p.21 10.2 Restrictions on Trade Marks Used for Pharmaceuticals and Medical Devices p.21 10.3 IP Protection for Trade Dress or Design of Pharmaceuticals and Medical Devices p.22 10.4 Data Exclusivity for Pharmaceuticals and Medical Devices p.22 11. COVID-19 and Life Sciences p.22
Dr. Reed has received grant funding from Bayer. Dr. Joffe is a consultant for Merck & Co, Inc, NeRRe Therapeutics, Mitsubishi Tanabe Pharma America Inc, SAGE Therapeutics. Dr. Joffe has received grant funding from Merck & Co, Inc. Dr. Cohen has received research funding from Cephalon, Inc, JayMac Pharmaceuticals, Takeda/Lundbeck Pharmaceuticals.
Pharmaceuticals and Medical Devices Safety Information No. 367 - 6 - October 2019 4. For facilitation of the use of RMP (1) Background As stated in the Pharmaceuticals and Medical Devices Safety Information No.358 5), according to the survey conducted by PMDA in the fiscal year (FY) 2017, the percentage of facilities that
* The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. Background. Three themes were discussed: 1.Ensuring early access to innovative pharmaceuticals & medical devices, and enhancing the safety measures 2.The role of community pharmacies and pharmacists, and the secure access to medicines
Standard Operating Procedures . Analysis of Pharmaceuticals and Personal Care Products by LC/MS . This guidance document was prepared to assist research assistants, post-docs and lab technicians in conducting analysis of pharmaceuticals, personal care products (PPCPs) and related compounds in the UMass Environmental Engineering research .
paper no.1( 2 cm x 5 cm x 0.3 mm ) and allowed to dry sera samples at 1: 500 dilution and their corresponding at room temperature away from direct sun light after filter paper extracts at two-fold serial dilutions ranging that stored in screw-capped air tight vessels at – 200C from 1: 2 up to 1: 256.
