Wired News – Amphastar Pharmaceuticals Declares Approval of ANDA for Sodium Nitroprusside Injection

LONDON, UK / ACCESSWIRE / December 21, 2017 / Active-Investors.com has just released a free report on Amphastar Pharma, Inc. (NASDAQ: AMPH). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AMPH. On December 19, 2017, the specialty pharmaceutical Company that mainly focuses on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable and inhalation products, declared that the US Food and Drug Administration has granted approval of its abbreviated new drug application (ANDA) for Sodium Nitroprusside Injection 25mg/mL, 2mL single dose vial. Register today and get access to over 1000 Free Research Reports by joining our site below:

www.active-investors.com/registration-sg

Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Amphastar Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=AMPH

Usage of the Sodium Nitroprusside Injection

The Sodium Nitroprusside Injection has been indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis. It has also been designated for producing controlled hypotension in order to reduce bleeding during surgery as well as for the treatment of acute congestive heart failure.

The FDA has suggested that this newly approved product of Amphastar is therapeutically equivalent to Nitropress® (i.e. Sodium Nitroprusside Injection) sold in the United States by Valeant Pharmaceuticals.

Amphastar plans to launch the Sodium Nitroprusside Injection in the first quarter of 2018.

Implications for Amphastar

The approval of Amphastar’s Sodium Nitroprusside Injection would expand the Company’s product offerings in the generic injectable portfolio. Besides, it would also strengthen its vertical integration strategy, as the Active Pharmaceutical Ingredient in this product is being manufactured by ANP, Amphastar’s Chinese subsidiary.

As per recent IQVIA data, the US brand and generic sales of Sodium Nitroprusside Injection, 25 mg/mL, 2mL vials were approximately $73.8 million for the 12 months ending September 30, 2017.

Amphastar’s Robust Product Pipeline

At present, Amphastar has three abbreviated new drug applications, or ANDAs filed with the FDA, three biosimilars products and 11 generic products in development.

These products have significant market value. For instance, the three new ANDAs target products with a market size of more than $0.5 billion. The biosimilars products comprise products with a market size of $15.0 billion, while the generic products target a market of over $12.0 billion. This market information is based on the IQVIA data for the 12 months ending September 30, 2017.

Besides, Amphastar’s proprietary pipeline also includes NDAs for Primatene® Mist and intranasal naloxone.

Approval of Medroxyprogesterone Acetate Injectable Suspension

Another important development for Amphastar is that, on November 29, 2017, FDA granted approval for two of its abbreviated new drug applications for Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg/mL, 1mL vial, and 1mL prefilled syringe, respectively, indicated for the prevention of pregnancy. The Company intends to launch this product in the first quarter of 2018.

As per IMS Health, US brand and authorized generic sales of Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg/mL, 1mL vials, and 1mL prefilled syringes were around $316 million for the 12 months ending September 30, 2017.

Stock Performance Snapshot

December 20, 2017 – At Wednesday’s closing bell, Amphastar Pharma’s stock marginally climbed 0.68%, ending the trading session at $19.31.

Volume traded for the day: 214.74 thousand shares.

Stock performance in the last month – up 5.35%; previous three-month period – up 17.74%; past six-month period – up 9.41%; and year-to-date – up 4.83%

After yesterday’s close, Amphastar Pharma’s market cap was at $861.61 million.

Price to Earnings (P/E) ratio was at 4827.50.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers-Other industry.

Active-Investors:

Active-Investors (A-I) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. A-I has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

A-I has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

The non-sponsored content contained herein has been prepared by a writer (the “Author”) and is fact checked and reviewed by a third-party research service company (the “Reviewer”) represented by a credentialed financial analyst [for further information on analyst credentials, please email info@active-investors.com. Rohit Tuli, a CFA® charter-holder (the “Sponsor”), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by A-I. A-I is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

NO WARRANTY

A-I, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. A-I, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, A-I, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither A-I nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://active-investors.com/legal-disclaimer/.

CONTACT

For any questions, inquiries, or comments reach out to us directly. If you’re a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: info@active-investors.com

Phone number: 73 29 92 6381

Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Active-Investors

ReleaseID: 484754