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:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening ... industry leaders in advanced audiology and hearing aid technology, ... ™, the world,s first internet connected hearing aid that ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... ,world firsts,: , TwinLink™ - the first ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
(Date:6/24/2016)... ... 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited to ... Recovery® program to drive cancer patients to and from their cancer treatments. Comfort ... quality of life and ongoing independence. Getting to and from medical treatments is ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s ... the world, and the most handsome men, look naturally attractive. Plastic surgery should ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
Breaking Medicine News(10 mins):