Navigation Links
JCM Passes Internal Quality Assessment for Azithromycin API Production
Date:11/9/2011

CHENGDU, China, Nov. 9, 2011 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in the development and sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine (TCM), branded generics and active pharmaceutical ingredients (API) announced that following the initial phase of operation, the Jiangchuan Macrolide Facility (JCM) has passed the internal quality assessment for its first batch of production of Azithromycin API.

A series of data points have been collected in terms of the purity, intermediates contents, stereochemistry, stability and the quality in comparison with the national standard of Azithromycin API that were issued in the latest version (2010) of Pharmacopoeia of China. Various parameters for quality control purposes were also measured during the production process. The results showed that Azithromycin API made at JCM has met the quality standards stipulated by China's State Food and Drug Administration (SFDA).

TPI reaffirms the November time line for its Good Manufacturing Practice (GMP) inspection.

About Azithromycin quality control

Azithromycin is a macrolide antibiotic related to erythromycin. It is used primarily to treat various bacterial infections caused by respiratory pathogens, such as Aerobic gram-positive microorganisms and Aerobic gram-negative microorganisms. Azithromycin prevents bacterial cells from manufacturing specific proteins necessary for their survival. Azithromycin is rapidly absorbed and is widely distributed to tissues and becomes concentrated in cells. Peak plasma concentrations are achieved within 2 to 3 hours. Since Azithromycin is synthesized from Erythromycin, impurities will undergo the same modifications and the Azithromycin analogues of these impurities can be found in Azithromycin bulk samples. In addition, degradation products of Azithromycin as well as intermediate compounds of the semi-synthesis may be present as well. The detection and assessment of the purity of the Azithromycin sample become the key element for quality control.

About TPI

Headquartered at Chengdu, China, TPI is a pharmaceutical company that specializes in the development, manufacturing, marketing and sales of patented biopharmaceutical, modernized traditional Chinese medicines, branded generics and active pharmaceutical ingredients (API). TPI currently manufactures a comprehensive portfolio of 58 products, 24 of which are listed in the highly selective national medicine reimbursement list, 7 are included in the essential drug list of China. TPI's pipeline targets various high incidence healthcare indications. TPI has an extensive nationwide distribution network with a sales force of 730 sales representatives out of totaled 1,365 employees.

For more information about TPI, please visit:  http://www.tianyinpharma.com

Safe Harbor Statement

The Statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

For more information, please visit: http://www.tianyinpharma.com, or email: ir@tpi.asia

Tel: +86-28-8551-6696 (Chengdu, China)
+86-134-3655-0011 (China)
Address:
Tianyin Pharmaceutical Inc.
23rd Floor, Unionsun Yangkuo Plaza      
No. 2, Block 3, South Renmin Road
Chengdu, 610041
China


'/>"/>
SOURCE Tianyin Pharmaceutical Co., Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Simceres Branded Generic Formulation Biqi Passes EU-GMP Inspection
2. German Patient Surpasses 5 Years of Support on DuraHeart™ Left Ventricular Assist Device
3. Acumen nEHR Surpasses 1,000 Nephrology Providers
4. Use of TIGR® Matrix Surgical Mesh in Multi-Center Randomized Controlled TRAM Flap Study Passes 20 Patient Mark and Wins Praise from Participating Surgeons
5. Netsmart Technologies Insight Public Health Software Passes ARRA Certification Tests
6. Caliper Life Sciences IVIS® Optical Imaging System Adoption Surpasses 1000 Units: Validated Drug Research, Discovery and Development Tool Enables Advances in Personalized Medicine
7. STAAR Surgicals Visian® ICL Surpasses 200,000 Implants
8. Lilly Surpasses United Way 2010 Campaign Goal
9. Health Robotics Surpasses 100 Installations Milestone and Acquires Two I.V. Room of the Future Partner Companies
10. Simceres Diosmectite API Passes EU-GMP Inspection
11. Osteotechs MagniFuse(TM) Distributed to 68 U.S. Hospitals as Product Revenue Surpasses $1 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... JACKSONVILLE, Florida , April 28, 2016 ... in the development of innovative peptide and gene-based immunotherapeutics and ... announced it will be presenting at the 3rd Annual ... - 5 th , 2016 at Caesars Palace in Las ... at 8.00 am on Wednesday, May 4 th by ...
(Date:4/27/2016)... 27, 2016  Hologic, Inc. (Nasdaq: ... for the fiscal second quarter ended March 26, ... $0.24 increased 41.2%, and non-GAAP diluted EPS of ... 5.8% on a reported basis, and 6.3% on ... posted another good quarter, highlighted by 14.6% growth ...
(Date:4/27/2016)... 27 Avril 2016   ... de +5% sur le trimestre, soutenu par une ... Croissance de +16% des ventes aux ... Mauna Kea Technologies (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), ... annonce aujourd,hui son chiffre d,affaires pour le premier ...
Breaking Medicine Technology:
(Date:4/29/2016)... Waltham, MA (PRWEB) , ... April 29, 2016 ... ... 1st, the Two Ten Footwear Foundation, the national charitable foundation serving the footwear ... activities. With 8,000 volunteers representing more than 130 companies across 23 states during ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... Awakening , announces the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress ... Onnit brain and mood optimization products to the store is just one more ...
(Date:4/29/2016)... Atlanta, Georgia (PRWEB) , ... April 29, 2016 , ... ... 60 rural hospitals across the Southeast, celebrated the signature of Gov. Nathan Deal on ... by Rep. Geoff Duncan (R - Cumming), offers a 70% tax credit to individuals ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... ... advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and MIRACLES") ... Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie Siegel, ...
(Date:4/29/2016)... ... April 29, 2016 , ... Conditions were ideal for Global Lyme Alliance’s (GLA) ... with sunny skies, a light breeze and temperatures in the 60s. Over 400 runners, ... Run and Walk and 1-mile walk were held to increase awareness about Lyme ...
Breaking Medicine News(10 mins):