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:3/23/2017)... LONDON , March 23, 2017 ... comprehensive research report created through extensive primary research ... research, the report aims to present the analysis ... basis of Procedure (Replacement and Repair); Replacement Procedure ... (TAVR)), Repair By Technique (Surgical Devices, Balloon Valvuloplasty, ...
(Date:3/23/2017)... 23, 2017  The U.S. Food and Drug Administration ... treatment of adults and pediatric patients 12 years and ... who have not received prior chemotherapy. This is the ... form of skin cancer. "While skin cancer ... a rare form called Merkel cell cancer have not ...
(Date:3/23/2017)... SAN DIEGO and VANCOUVER, British ... Inc. (NASDAQ: SPHS ) (the "Company" or ... for the treatment of urological diseases, today announced that ... which evaluated the drug as a focal treatment for ... on March 26, 2017 at the 32 nd ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... Vighter established its NAEMT Authorized ... providing Prehospital Trauma Life Support (PHTLS) course scholarships to four medics assigned to ... developed in cooperation with the American College of Surgeons to promote critical thinking ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... world countries to hospitals in the United States, it’s a threat that is ... current obstacles facing infection prevention and offers strategies for the healthcare community to ...
(Date:3/24/2017)... Farifax, VA (PRWEB) , ... March 24, 2017 , ... ... its 2017 Quest Awards . The annual awards, now in their 12th year, ... marketing peers selects the winners. , In 2016, the awards were retooled to recognize ...
(Date:3/24/2017)... ... , ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce the ... clinic is the group’s 7th location in San Antonio and 23rd in Texas. ... care from the clinic, which opened March 22, 2017. , The team ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... related services to families and business owners across eastern Michigan, is connecting with ... families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry works to ...
Breaking Medicine News(10 mins):