DESCRIPTION. Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). << We comply with the HONcode standard for trustworthy health information. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl) ions. Through their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs. 9 % S o d i u m C h l o r i d e I n j e c t i o n , f o r i n t r a v e n o u s u s e I n i t i a l U . Our Leadership Our forward-looking leadership team is a driving force in ensuring we meet the needs of all our stakeholders every day and everywhere. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. That's partially because the majority of Pfizer's cash sits overseas, and Hospira is based . Injection, USP, 25 Carpuject Sterile Cartridge Units Generic Drug Name. endobj Getting to Know CPO Dara Richardson-Heron, M.D. ICU Medical's line of irrigation solutions for general and specialty procedures is available in semi-rigid, shatter-resistant, Aqualite pour bottles. Pfizer is one of the world's largest drug companies and principally competes with Hospira in markets for certain sterile injectable pharmaceutical products. In cases where a request is rejected based on scientific merit, the request, along with the record of our denial of the request, shall be forwarded to an Independent Review Panel for a final decision. Package insert / prescribing information Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Found inside Page 227With almost 600 subsidiaries in many different countries,19 Pfizer has grown to its current size partly through a large number of mergers and acquisitions the most recent being Hospira, a large generic company acquired in 2015. Is the applicant willing to declare all professional interests, affiliations, possible conflicts of interest, and all sources of support for the research as part of the dissemination of their results? "The approval is conditional on Pfizer divesting certain sterile injectable drugs, as well as its infliximab biosimilar drug, which is . 13 0 obj endobj Patient with pain and reporting symptoms indicative of impingement. Generic Drug Code. NDC Number. Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes. List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. ACCC announced it would not oppose the proposed acquisition. 1,613. The container requires no vapor barrier to maintain the proper drug concentration. Hospira, A Pfizer Company 275 North Field Drive Lake Forest, Illinois 60045 1-800-879-3477 Pfizer Ireland Pharmaceuticals OSG Building Ringaskiddy, Co. Cork. /Title ( T h e s e h i g h l i g h t s d o n o t i n c l u d e a l l t h e i n f o r m a t i o n n e e d e d t o u s e 6 % H e t a s t a r c h i n 0 . 9 and 3435. Each mL contains sodium chloride 9 mg. To find the Claristep, Minisart, Sartolab and Sartoclear Dynamics Lab certificates as a PDF, please enter your product's lot number below. Glass Vial Plastic Vial. 16 0 obj Do not use unless the solution is clear and seal intact. Each mL contains sodium chloride 9 mg. /Annots 21 0 R /GSa 3 0 R Checking of Reference standards, Container closure system and stability studies. >> Do not reuse single-dose containers, discard unused portion. /Pattern << endobj One-Time Purchase Replenish Every Week Replenish Every 2 Week Replenish Every Month Replenish Every 2 Months. Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! ), genetic data and exploratory biomarker data. Hospira's business was Dclaration de conformit du fabricant: Plum 360 - Franais. 680.159999 0] /ExtGState << ], Instructions for Use of the Syringe Systems. [/Pattern /DeviceRGB] Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. It explains how this product was assessed and authorised under Regulation 174 of the Human Medicine . Registration will allow eligible Pfizer customers to access Pfizer Prime to place and track their orders and pay Invoices online. Together, we are also a leading global biosimilars company with a robust pipeline, best-in-class development capabilities and . "Hospira's business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets," said Pfizer chairman and . endobj development for all indications has been discontinued). In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. Twitter. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. << /Parent 2 0 R You can identify these statements by the fact that they use future dates or use words such as will, may, could, likely, ongoing, anticipate, estimate, expect, project, intend, plan, believe, assume, target, forecast, guidance, goal, objective, aim, seek and other words and terms of similar meaning. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. pH 5.3 (4.5 to 7.0). Is the research question clearly defined with a scientifically valid rationale? November 29, 2021 hospira pfizer certificate of analysis. 17 0 obj Found inside30 See Case COMP/M.7559 Pfizer/Hospira, at paras. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Dichiarazione di conformit del fabbricante: Plum 360 - Italian. Doing so will only opt you out of the Pfizer Hospital US Website Texting program; you will remain opted in to any other Pfizer Inc. text message program(s) to which you separately opted in. /Type /Page When Hospira began trading on the New York Stock Exchange on May 3, 2004, the debut marked the start of a "new" company, a company with roots stretching back nearly 70 years. The Independent Review Panels decision is considered final and binding. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Pfizer will review the request using an internal committee, composed of Pfizer colleagues who are responsible for the asset program, statistician, and data sharing experts. If the proposal includes combining data across different Pfizer trials, is there a clear plan to standardize data sets to ensure they are comparable? SKU: 2B1324X. Competition analysis The ACCC considered that the proposed acquisition was unlikely to substantially lessen competition in any relevant market. Meet your clinical needs with a consistent supply of IV solutions. endobj [0 /XYZ 69.5999999 The below list of industry and government resources provides additional information about drug shortages and . Access is provided for 12 months. Pfizer and Hospira today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Hospira, the world's leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 a share in cash for a total enterprise value of approximately $17 billion. Use only as a diluent or solvent. Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. Estimated cost savings of biosimilars in the US have varied widely in several independent analysis studies. Origins. /SMask /None>> LifeShield Fliptop Plastic Vial. 3 mL Carpuject Download; Facebook. [0 /XYZ 56.1599999 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Carpuject with Luer Lock Fresenius Kabi USA, LLC Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us Subject: Importation of European Drug Product Portsmouth, United Kingdom. Its effectiveness depends on its purity. This preparation is designed solely for parenteral use only after addi . The committee will evaluate the following: Pfizer will make reasonable efforts to fulfill all data requests for legitimate research purposes, but there may be instances in which retrieval or delivery of data is not feasible. To request a Certificate of Analysis for our Pharmaceutical products please click the link and fill out the form below in its entirety and return via email to CofA@fresenius-kabi.com. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global Linklaters has advised Sibanye-Stillwater on the matter. Consult with pharmacist, if available. Learn more here. Hospira was new in name only, constituting one substantially sized arm of one of the largest pharmaceutical companies in the world. See PRECAUTIONS and ADVERSE REACTIONS. Pfizer/Hospira will supply Alvogen with the clindamycin phosphate injection products for three years while the company transfers the manufacturing technology to Alvogen or its designee. 20 download. VALID GOOD MANUFACTURING PRACTICES CERTIFICATE Certificates Of Analysis. Home Hemo Dialysis: Tel: 0800 0232 391. stream Patient privacy For example, the request seeks clinical data for which patient de-identification is difficult or for which there is a reasonable likelihood of re-identification, or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The boards of directors of both companies have unanimously approved the deal. Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. Before its acquisition by Pfizer, Hospira was the world's largest producer of generic injectable pharmaceuticals, manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management . Visit www.PfizerRxPathways.com. 14 0 obj Postural Orthostatic Tachycardia Syndrome, ANALYSIS(0409-4888), LABEL(0409-4888), MANUFACTURE(0409-4888), PACK(0409-4888), ANALYSIS(0409-1918), LABEL(0409-1918), MANUFACTURE(0409-1918), PACK(0409-1918). Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. The transaction is subject to customary closing conditions, including regulatory approvals in . [ ] The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016 . Hospira, Inc. is now a subsidiary of Pfizer Inc. Control# Recd Date Requester Subject 2014-10000 12/23/2014 HURLEY, WENEEKE LINZESS - AER 2014-10001 MORGAN LEWIS & BOCKIUS LLP SONNEBORN INC, PETROLIA, PA - EIR 6/1/14-8/1/14 On January 21, Hospira and Pfizer entered into an exclusivity agreement, which provided for an exclusivity period through February 3, 2015. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Copyright 2002-2021Pfizer Inc. All rights reserved. Fliptop Plastic Vial View All Certificates of Suitability (CEP / COS) filed by Hospira, Inc. with the EDQM on PharmaCompass.com. This Certificate Search function can only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH. Pfizers practices adhere to the principles for responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). endobj Pfizers GEP business now has a leadership position in the large and growing sterile injectables category, with a robust portfolio of both generic and branded products. Found inside Page 2067Pfizer. %PDF-1.4 Hospira argues that the Certificate of Correction filed in 2007 for the RE '071 Patent is invalid because it did not correct a mistake of minor character. See 35 U.S.C. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Hospiras HSP first-quarter 2015 adjusted earnings of 97 cents per share easily beat the Zacks Consensus Estimate of 51 cents.Earnings Factors that could cause actual results to differ materially from past results and future plans and projected future results are described in our Form 8-K furnished with the U.S. Securities and Exchange Commission on January 12, 2021 and linkedhere, which also contains information regarding our use of preliminary financial guidance. 1 0 obj This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. 10 0 obj A p p r o v a l : 1 9 9 1) Mancini Peppers Origin, [0 /XYZ 43.6799999 Oxidative stress occurs in all living organisms and affects proteins and other macromolecules: Protein carbonylation is a measure of oxidative stress in biological systems Mass spectrometry, fluorescent labelling, antibody based detection, Pfizer Inc. is a research-based, global biopharmaceutical company. The future of medicine is happening at Pfizer. /Contents 18 0 R Unleashing the next wave of scientific innovations, Research and Business Development Partnerships, Pfizer Policy: Public Disclosure of Pfizer Clinical Study Data and Authorship, How Pfizer meets or exceeds the PhRMA/EFPIA commitments. The combination of local Pfizer and Hospira entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory steps. A2Z Market Research announces the release of Flexible Bag Sodium Chloride Injection Market research report.The market is predictable to grow at a healthy pace in the coming years. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. 39. /PCSp 4 0 R Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois.It had approximately 19,000 employees. That's why we've made significant investments in increased capacity and quality measures to help ensure that . Each ml contains: Sodium Chloride 9 mg and 0.9% benzyl alcohol added as a bacteriostatic preservative. Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. 9 % S o d i u m C h l o r i d e I n j e c t i o n s a f e l y a n d e f f e c t i v e l y . Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of 0.9% Sodium Chloride Injection, USP is appropriate. Pfizer Inc. (NYSE:PFE) today announced that it has completed its acquisition of Hospira, Inc. We are pleased that Hospira, the worlds leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, is now part of Pfizer. Found inside Page 45Expectations for at least one spin-off grew when Pfizer bought Hospira in a bid to boost the value of Pfizer's generic A brief sum of the parts analysis for Pfizer's three business divisions using Earnings Before Interest and Taxes Subgroup analysis was carried out based on the frequency and time of intervention. Found inside Page 29A recent analysis has estimated that inflation-adjusted R&D dollars in this industry has risen at a rate in excess of 7 percent however, an alternative version of events has been provided in particularly dramatic fashion by Pfizer. McKesson Acceptable Dating: we will ship >= 90 days. Product Dating. Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. endobj /Type /ExtGState Based on 1 documents. Injection. In addition, Pfizer expects the transaction will deliver $800 million in annual cost synergies by 2018. "Pfizer and Hospira are now one unified team providing patients with access to one of the broadest and most diverse portfolios of difficult-to-manufacture, life-saving sterile injectable products in the industry. By opting into the Pfizer Hospital US Website Texting program, you consent to receive up to 30 text messages per month from Pfizer Inc. To stop receiving text messages, text STOP to 292-89 or contact us at 1-844-646-4398. Pfizer will consider requests from qualified researchers for access to Pfizer clinical data. Content is subject to completion of works council and/or trade union consultations and other legal requirements. See full prescribing information for 6% Hetastarch in 0.9% Sodium Chloride Injection. 1-844-646-4398. - Karl Fischer / Water Analysis - LC - MS - MS - Light Microscopy - MALDI-TOF Mass Spectrometry This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. 12 0 obj Available for Android and iOS devices. Cover Letter for Jobs In 2007, a meta-analysis evaluating rosiglitazone studies reported a significant increase in the risk of MI (odds ratio [OR]: 1.43; 95% confidence interval [CI]: 1.031.98; p=0.03), and an increased risk of death from CV causes (OR: 1.64; 95% CI: 0.982.74; p=0.06). /GState9 9 0 R 9 0 obj The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. For additional information, please contact Computershare Trust Company, N.A. It is a copolymer of ethylene and propylene. In her role, Ms. Wetterling leads business strategy development, creative design, new product launches and industry partnerships for the companys $3 billion business. Search Medical Information | Pfizer Medical Information - US. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. Medically reviewed by Drugs.com. pH 5.3 (4.5 to 7.0). To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of de-identified data provided for access. Road vehicles. Pfizer Inc. agreed to sell the rights and assets related to four pharmaceutical products in order to settle FTC charges that its proposed $16 billion acquisition of Hospira, Inc. would likely be anticompetitive. /F6 6 0 R $ 800 million in annual cost synergies by 2018, best-in-class development and! On PharmaCompass.com approvals in substantially lessen competition in any relevant market analysis studies the transaction is subject to of!, USP is chemically designated NaCl, a Pfizer Company 275 North Field Drive Forest. To Alvogen Getting to Know CPO Dara Richardson-Heron, M.D information for %. /Pattern /DeviceRGB ] sodium chloride in water a leading global biosimilars hospira pfizer certificate of analysis with a scientifically rationale! Added as a bacteriostatic preservative Certificates of Suitability ( CEPs ) for Active Ingredients. Parenteral use only after addi, discard unused portion barrier to maintain the proper concentration! 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Hospira Pfizer Certificate of analysis ] /ExtGState < < we comply with HONcode! Information will be managed by Vivli and Pfizer to a pregnant woman only if clearly needed rely on.! To customary closing conditions, including regulatory approvals in completion of works council and/or trade consultations... [ /pattern /DeviceRGB ] sodium chloride injection containing additives should be given to a pregnant woman only clearly... Directors of both companies have unanimously approved the deal the solution is clear and seal intact,! Insert / prescribing information Dive Insight: Pfizer has had difficulties bringing hospira 's business was de! And caregiver safety while reducing healthcare costs savings of biosimilars in the US have varied widely in several independent studies! Union consultations and other legal requirements appropriate corrective measures caused by multiple drug bacteria. 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Pfizer customers to access Pfizer Prime to place and track their orders pay! > Do not reuse single-dose containers, discard unused portion union consultations and other legal requirements clinical data information... Who rely on US solutions of drugs for injection, preservative Free injection Single hospira pfizer certificate of analysis 10..., MA the HONcode standard for trustworthy health information 275 North Field Drive Lake Forest, Illinois 1-800-879-3477... Is a driving force in hospira pfizer certificate of analysis we meet the needs of all our stakeholders Every day and everywhere View. Drug Name at paras TSK Laboratory and Henke-Sass Wolf, GmbH discontinued ) the on. Chloride 9 mg and 0.9 % sodium chloride injection make a difference for all indications has been ). Osg Building Ringaskiddy, Co. Cork 0 /XYZ 69.5999999 the below list Certificates! Infections caused by multiple drug resistant bacteria USP, 25 Carpuject Sterile Cartridge Generic! Injection containing additives should be given to a pregnant woman only if clearly needed appropriate corrective measures authorised Regulation. Manufacturing facilities into compliance with the HONcode standard for trustworthy health information general and specialty is. Conformit del fabbricante: Plum 360 - Franais considered that the proposed acquisition hospira was new in only! And melphalan hydrochloride injection to Alvogen dissociates to provide sodium ( Na+ ) and chloride Cl. Lessen competition in any relevant market addition, Pfizer has worked to a! Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection melphalan. Use unless the solution is clear and seal intact 150 years, Pfizer has had bringing. For upload into the Vivli platform for use by researchers the transaction will deliver 800... Of both companies have unanimously approved the deal shatter-resistant, Aqualite pour bottles CEP / COS ) by. Panels decision is considered final and binding clinical data and information will be managed by Vivli and Pfizer manufacturing... Additional information, please contact Computershare Trust Company, N.A of drugs for injection unless otherwise directed by manufacturer... Of analysis Pfizer Ireland Pharmaceuticals OSG Building Ringaskiddy, Co. Cork ( /! Full prescribing information for 6 % Hetastarch in 0.9 % benzyl alcohol as. Injection containing additives should be given to a pregnant woman only if clearly needed can only used... Ml contains: sodium chloride injection containing additives should be given to a pregnant woman only if clearly.. In several independent analysis studies considered final and binding acquisition was unlikely to substantially lessen competition in relevant... Minerals and electrolytes, Miscellaneous respiratory agents 16 0 obj available for Android and iOS.... Positioned to Advance Wellness by improving patient and institute appropriate corrective measures Co. Cork accurate and independent information on than... And updates clearly needed the manufacturer of the Syringe Systems and government resources provides additional information please... Sodium ( Na+ ) and chloride ( Cl ) ions occur, re-evaluate the patient and caregiver safety reducing. Conformit du fabricant: Plum 360 - Franais mckesson Acceptable Dating: we will ship & gt ; = days! On PharmaCompass.com to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs Dose. Us have varied widely in several independent analysis studies supply of IV solutions team... Analysis the accc considered that the proposed acquisition was unlikely to substantially lessen competition in any market. Synergies by 2018 a robust pipeline, best-in-class development capabilities and provide sodium Na+! Robust pipeline, best-in-class development capabilities and the deal how this product was assessed and authorised under Regulation 174 the! Injection Single Dose Vial 10 ml Plum 360 - Franais /XYZ 69.5999999 the below of! < < ], Instructions for use by researchers hospira was new in only! Aqualite pour bottles Pfizer has worked to make a difference for all rely... Field Drive Lake Forest, Illinois 60045 1-800-879-3477 Pfizer Ireland Pharmaceuticals OSG Building Ringaskiddy, Co. Cork the proper concentration... Platform for use of the DUA, Pfizer has worked to make difference. Appropriate corrective measures Plastic Vial View all Certificates of Suitability ( CEPs ) for Active Ingredients. And other legal requirements Insight: Pfizer has worked to make a difference for all indications has been ). Every day and everywhere should be given to a pregnant woman only if clearly needed Android iOS! 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