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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

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Dr. Reddy’s avoids pitfalls of Ranbaxy, Wockhardt by cutting workers out of production Read more: Dr. Reddy’s avoids pitfalls of Ranbaxy, Wockhardt by cutting workers out of production


FDA pressure pushes Indian drugmakers to move away from relying predominantly on low-wage workers

The execs at Dr. Reddy’s Laboratories have taken notice as some of its competitors in India have run afoul of the FDA over loose manufacturing standards. The actions have meant banned plants and plummeting revenues for Ranbaxy Laboratories and Wockhardt. To avoid that fate, Dr. Reddy’s and some other Indian drugmakers have decided it is worth investing hundreds of millions of dollars for new plants and equipment in a country that has traditionally relied on cheap human labor.

Anji Reddy founded Dr Reddy’s in 1984 with Rs.25 lakh in initial capital. Photo: Mint

India business robust in terms of growth: Glenmark….videos


 

SOME LINKS ON VIDEOS

CLICK TO VIEW

India business robust in terms of growth: Glenmark on Q1 

profit.ndtv.com/…/news/video-india-business-robust…

Aug 2, 2013

NDTV Profit News Video Clip on India business robust in terms of growth: … chairman and managing director …

Pharma Trends: Global Medicine Spending to Pass $1 Trillion in 2014


This year will mark a milestone in the pharmaceutical industry’s growth as drug sales will exceed $1 Trillion. This was the finding of IMS Health in their new report on the spending on pharmaceuticals and trends that will affect it between now and 2017.
Two factors will be the major drivers of this growth, increased spending on medicines in emerging markets and increased spending on new drugs for cancer and orphan diseases.

http://msg-latam-sfb.blogspot.in/2013/12/pharma-trends-global-medicine-spending.html

BIOSIMILARS MARKET IS NOT EQUIVALENT TO GENERICS MARKET


 

read this at

http://msg-latam-sfb.blogspot.com.ar/2014/05/biosimilars-market-is-not-equivalent-to.html

Lupin forms joint venture with Yoshindo


 

Lupin forms joint venture with Yoshindo
Indian pharmaceutical company Lupin is to create a new biosimilars company in a joint venture with Japanese pharmaceuticals company Yoshindo. The new company, to be called YL Biologics (YLB), will be jointly managed by both partners and will develop biosimilars including regulatory filings and…

read at

http://www.manufacturingchemist.com/news/article_page/Lupin_forms_joint_venture_with_Yoshindo/97981/cn48579?dm_i=8EU,2FAE5,9ETTTY,8T8OK,1

 

Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi


Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi 

Total Payment received for GBR 500 monoclonal antibody programme from Sanofi is USD 55 Mn 

MUMBAI, April 15, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received USD 5 million as

milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta1) integrin monoclonal antibody. GBR 500 is a first-in-class therapeutic monoclonal antibody for chronicautoimmune disorders.

Glenmark has received from Sanofi already USD 50 Mn as an upfront payment in FY2011-12. Hence, the total amount received by Glenmark from Sanofi for its first in class VLA-2monoclonal antibody is USD 55 million

 

read at

Glenmark – Updates

http://www.moneycontrol.com/stocks/stock_market/corp_notices.php?autono=790416

(copy paste on browser)

MD and CEO Mr Glenn Saldanha

 

 

old updates

Glenmark GBR 500 enters into Phase II clinical development for ulcerative colitis

17 September 2012

Glenmark Pharmaceuticals, a wholly-owned subsidiary of Glenmark Pharmaceuticals, has commenced the Phase II study of GBR 500 for ulcerative colitis.

GBR 500, an antagonist of the VLA2 (alpha2-beta1) integrin, is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders.

The randomised, double-blind, placebo-controlled study will investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC).

Glenmark Pharmaceuticals chief scientific officer Dr Michael Buschle said that UC represents an area of substantial unmet medical need, despite treatment advances in recent years.

“We’re pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial,” Buschle said.

The trial, which will be conducted at multiple clinical sites in North America and Europe, is expected to involve approximately 84 patients.

Patients participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks.

Glenmark has completed Phase I of GBR 500 in the US, won licensing rights to all therapeutic indications from Sanofi and is conducting the clinical development programme.

The trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders.

http://www.drugdevelopment-technology.com/news/newsglenmark-gbr-500-enters-into-phase-ii-clinical-development-for-ulcerative-colitis

 

MUMBAI, IndiaMay 16, 2011

Glenmark Pharmaceuticals Out-Licenses Novel Monoclonal Antibody, GBR 500, to Sanofi

Combined Upfront and Potential Development, Regulatory and Commercial Milestone Payments Could Total US$613 Mn

MUMBAI, India, May 16, 2011 /PRNewswire-FirstCall/ — Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announced today that it has entered into an agreement with Sanofi to grant Sanofi a license for the development and commercialization of GBR 500, a novel monoclonal antibody for the treatment of Crohn’s Disease and other inflammatory conditions. The transaction is expected to close in the coming month subject to customary closing conditions, including the expiration or early termination of the waiting period under the HSR Antitrust Improvements Act.

Under the terms of the agreement, Glenmark will receive an upfront payment of US$ 50 million, of which US$ 25 million will be paid upon closing of the transaction and US$ 25 million, which is contingent upon Sanofi’s positive assessment of certain data to be provided by Glenmark. In addition, Glenmark could receive potential success-based development, regulatory and commercial milestone payments. The total of these payments could reach US$613 Mn. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialized under the license.

GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions. Glenmark has completed Phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn’s Disease. Sanofi has licensed the rights to all therapeutic indications.

“There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases,” said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. “GBR500 brings an innovative approach to Sanofi’s Immuno-Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients”.

Glenn Saldanha MD and CEO of GPL, “This collaboration on a novel first-in-class monoclonal antibody validates Glenmark’s world-class innovative R&D capabilities in the drug discovery arena. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics”.

http://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-out-licenses-novel-monoclonal-antibody-gbr-500-to-sanofi-121889273.html

Sun Pharma has bought Ranbaxy for $4 billion to create the world’s fifth-biggest generic drugmaker.


Sun buys Ranbaxy for $4 billion

Dilip sanghvi, sun pharma promoter

The move will make the company the largest pharma firm in India, while Daiichi Sankyo – majority owner of Ranbaxy – will become the second largest shareholder in Sun Pharma with a 9% stake and the right to nominate one director to Sun Pharma’s Board of Directors. http://www.pharmatimes.com/Article/14-04-07/Sun_buys_Ranbaxy_for_4_billion.aspx

Read more at: http://www.pharmatimes.com/Article/14-04-07/Sun_buys_Ranbaxy_for_4_billion.aspx#ixzz2yGIjkMob

 

 

Dilip Shanghvi, Managing Director of Sun Pharma said in a release, “Ranbaxy has a significant presence in the Indian pharma market and in the US where it offers a broad portfolio of ANDAs and first-to-file opportunities. In high-growth emerging markets, it provides a strong platform which is highly complementary to Sun Pharma’s strengths,”

Under the agreement, Ranbaxy shareholders will get 0.8 shares of Sun Pharma for each Ranbaxy share.

Arun Sahwney, managing director and chief executive officer of Ranbaxy said in a statement, “Sun Pharma has a proven track record of creating significant long-term shareholder value and successfully integrating acquisitions into its growing portfolio of assets,”

Who Will Benefit?

Daiichi Sankyo Co. Ltd is the parent company of Ranbaxy as they acquired it from previous promoters and investors. As soon as Ranbaxy was acquired, their plants came under a scanner from US Food and Drug Administration (FDA), which troubled Daiichi as their own reputation was under stake.

Now, they will be the most relived entity as Sun Pharma will manage all such cases pertaining to Ranbaxy. Daiichi will now control 9% of Sun Pharma as a result of the current acquisition.

Insiders are claiming that Daiichi will sell this 9% stake as well and come out of the business all together.

Ranbaxy shareholders have cheered this latest development as their shares have gained since the announcement of this deal.

Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 4 Mn. as research fee payment from Forest Laboratories Inc.


 

Total Payment received for the mpges-1 program from Forest Laboratories is USD 15 million

 

March 25, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received

USD 4 million as research fee payment from Forest Laboratories Inc. on a collaboration for the development of novel mPGES-1 inhibitors to treatchronic inflammatory conditions, including pain.

Under the terms of the agreement signed in FY 2012-13, Forest made USD 6 million upfront payment and also provided an additional USD 3 million

to support the next phase of work. In September 2013, Glenmark received an additional amount of USD 2 million as research fee payment from Forest Laboratories Inc.

Hence, the total amount received by Glenmark from Forest Laboratories Inc towards its novel mPEGS-1 inhibitors program is USD15 million.

read at

http://www.thehindubusinessline.com/companies/announcements/others/glenmark-pharmaceuticals-ltd-through-its-swiss-subsidiary-receives-usd-4-mn-as-research-fee-payment-from-forest-laboratories-inc-total-payment-received-for-the-mpges1-program-from-forest-laboratories-is-usd-15-million/article5829435.ece

pdf

Click to access Click_here_for_pdf_1808928a.pdf

LUPIN.. giant leap forward » All About Drugs


LUPIN.. giant leap forward » All About Drugs

TAKEDA PHARMACEUTICALS 武田薬品工業株式会社 ON THE RISE


Tadataka Yamada, M.D., Chief Medical & Scientific Officer of Takeda

TAKEDA US CHICAGO OFFICE

TAKEDA PIPELINE SEE LINKS BELOW

1    https://www.takeda.com/investor-information/annual/files/ar2013_10_en.pdf

2. http://www.takeda.com/research/files/pipeline_20131031_en.pdf

3  http://www.takeda.com/research/pipeline/

PDF PDF 1.0MB 18P

Takeda’s top executives had frequently pointed to TAK-875 as one of their best shots at coming up with an important new approach to treating diabetes. The drug is designed to spur insulin secretion in the pancreas and Takeda had confidently projected an approval in Japan in 2015 with a follow-up approval in the big U.S. market a year or two later.

The termination of the high-profile program caused some anxiety among investors. Takeda’s shares plunged 8% on the loss as analysts wondered how the pharma company could counter the loss of Actos, a $3.7 billion drug that accounted for about a quarter of its revenue in 2011.

Takeda won an approval on a trio of DPP-4 diabetes drugs–Nesina (alogliptin) and two combos with alogliptin, dubbed Oseni and Kazano–at the beginning of the year. But Takeda suffered some big delays in gaining acceptance, a common fate in this field, where regulators are particularly cautious about new drugs. And Merck  had already solidified its lead in the DPP-4 market with Januvia whileOnglyza trailed closely behind it. Takeda had hoped that a combination of TAK-875 and Januvia could help regain some lost market territory–but that dream has clearly vanished as well.

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CLIPPED

Takeda isn’t quite in the top 10 among global drugmakers, but the company boasts the 7th-largest pipeline in the industry, according to its presentation at the conference. Yamada noted that 31% of the pipeline assets are in late-stage trials. Millennium is leading development of three late-stage contenders, TAK-700 for prostate cancer, MLN9708 for multiple myeloma and MLN0002 for ulcerative colitis andCrohn’s disease.

In an effort to revive its diabetes franchise, Takeda is in the final stage of development for a first-of-a-kind GPR40 agonist called TAK-875, designed to provide glucose-dependent insulin secretion.

With a rich late-stage pipeline at Takeda, Yamada wants the company to focus on growing its ranks of earlier-stage drug candidates. To do this the company has landed a variety of deals, including the purchase of Intellikine for $310 million to acquire anti-cancer drugs and more recently the acquisition of Envoy Therapeutics last year for $140 million.

Takeda has formed a New Frontier Science group to scout out the hottest research in academia and elsewhere and form collaborations with scientists behind those innovations. At the J.P. Morgan conference, Yamada said, he was attending many meetings with members of the biotech community.

Takeda Pharmaceutical Company Limited (武田薬品工業株式会社 Takeda Yakuhin Kōgyō Kabushiki-gaisha?) is the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 30,000 employees worldwide and achieved $16.2 billion USD in revenue during the 2012 fiscal year.[1] The company is focused on metabolic disordersgastroenterologyneurologyinflammation, as well asoncology through its independent subsidiary, Millennium: The Takeda Oncology Company.[2] Its headquarters is located in Chuo-kuOsaka, and it has an office in NihonbashiChuoTokyo.[3][4] In January 2012, Fortune Magazine ranked the Takeda Oncology Company as one the 100 best companies to work for in the United States.

Takeda Pharmaceuticals was founded on June 12, 1781 and was incorporated on January 29, 1925.

Takeda’s Japanese logo

In 1977, Takeda first entered the U.S. pharmaceutical market by developing a joint venture with Abbott Laboratories called TAP Pharmaceuticals.[5]Through TAP Pharmaceuticals, Takeda and Abbott launched the blockbusters Lupron (leuprolide) in 1985 and Prevacid (lansoprazole) in 1995.

One of the firm’s mainstay drugs is Actos, a compound in the thiazolidinedione class of drugs used in the treatment of type 2 diabetes. Launched in 1999, Actos has become the best-selling diabetes drug in the world with $4 billion USD in sales during the 2008 fiscal year.[6]

In February 2005, Takeda announced its acquisition of San Diego, California-based Syrrx, a company specializing in high-throughput X-ray crystallography, for $270 million.[7]

In February 2008, Takeda acquired the Japanese operations of Amgen and rights to a dozen of the California biotechnology company’s pipeline candidates for the Japanese market.[8]

In March 2008, Takeda and Abbott Laboratories announced plans to conclude their 30-year old joint venture, TAP Pharmaceuticals, that had over $3 billion in sales in its final year. The split resulted in Abbott acquiring U.S. rights to Lupron and the drug’s support staff. On the other hand, Takeda received rights to Prevacid and TAP’s pipeline candidates. The move also increased Takeda’s headcount by 3,000 employees.[9]

In April 2008, Takeda announced that it was acquiring Millennium Pharmaceuticals of CambridgeMassachusetts, a company specializing in cancerdrug research, for $8.8 billion. The acquisition brought in Velcade, a drug indicated for hematological malignancies, as well as a portfolio of pipeline candidates in the oncology, inflammation, and cardiovascular therapeutic areas. Millennium now operates as an independent subsidiary, serving as the global center of excellence in oncology under its new name: “Millennium: The Takeda Oncology Company.” [10]

In May 2008, the company licensed non-exclusively the RNAi technology platform developed by Alnylam Pharmaceuticals, creating a potentially long-term partnership between the companies.[11]

On May 19, 2011, Takeda Pharmaceutical and Nycomed announced that Takeda will acquire Nycomed for  9.6 billion. The acquisition was completed by September 30, 2011.[12]

On April 11, 2012, Takeda Pharmaceutical and URL Pharma announced that Takeda will acquire URL Pharma for $800 million. The acquisition is expected to be completed within 60 days.

On 25 May 2012, Takeda announced the purchase of Brazilian pharmaceutical company Multilab by R$ 540 million.[13]

Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, inChuo-ku, Osaka, Japan

Takeda operates two primary bases in Japan in Osaka and Tokyo. Its United States subsidiary is based in Deerfield, Illinois, and all Global Operations outside of Japan and U.S. are based in Opfikon (Zurich), Switzerland. The company maintains research & development sites in Osaka and Tsukuba, Japan; San Diego andSan Francisco, United States; Cambridge, United Kingdom; and Singapore.[14]

The company has manufacturing facilities in Japan, China, Indonesia, Italy, and Ireland.[15] Following the Nycomed acquisition, the Takeda manufacturing sites have been extended with facilities in Argentina,Austria,Belgium,Brazil,Denmark, Estonia,Germany,Mexico,Norway and Poland. Takeda has overseas marketing presences in the U.S., UK, France, Italy, Germany, Austria, Switzerland, Spain, China, Taiwan, Philippines, Thailand, Indonesia, and Singapore. It has recently[when?] announced its first foray into Canada, Portugal, Spain, Mexico, and Ireland.[15]

AT INDONESIA

Products

Some of the key products that Takeda produces on behalf of partners include:[16]

AT UK

References

  1.  “Financial Results for Fiscal 2012” (PDF). Takeda Pharmaceutical Company Limited. May 9, 2013. Retrieved June 13, 2013.
  2. “Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes”. Newsblaze.com. 2009-08-28. Retrieved 2010-09-18.
  3.  “FAQ.” Takeda Pharmaceutical Company. Retrieved on February 2, 2011. “Q : Where is Takeda located? A : The Head Office is located in Osaka, Japan, and the Tokyo Head Office is located in Tokyo, Japan.”
  4.  “Overview.” Takeda Pharmaceutical Company. Retrieved on February 2, 2011. “Headquarters Head Office 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645” and “Tokyo Head Office 12-10, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-8668”
  5.  “TAP Pharmaceutical Products, Inc.: Private Company Information – BusinessWeek”. Investing.businessweek.com. 2008-04-30. Retrieved 2010-09-18.
  6. Decker, Susan (2009-07-06). “Takeda Sues Torrent to Stop Generic Copy of Actos Diabetes Pill”. Bloomberg. Retrieved 2010-09-18.
  7.  Somers, Terri (2005-02-08). “Japanese drug giant taking over Syrrx here | The San Diego Union-Tribune”. Signonsandiego.com. Retrieved 2010-09-18.
  8.  “Takeda, Amgen in exclusive tie-up for Japanese market”. MarketWatch. 2008-02-04. Retrieved 2010-09-18.
  9.  Marrazzo, Amanda (2008-05-15). “Featured Articles From The Chicago Tribune”. Archives.chicagotribune.com. Retrieved 2010-09-18.
  10.  “MILLENNIUM: The Takeda Oncology Company | About Millennium | Our History”. Mlnm.com. Retrieved 2010-09-18.
  11.  staff (2008-06-15). “Takeda Signs On as Alnylam’s Asian Partner for $150M Upfront”. Genetic Engineering & Biotechnology News (print) (Mary Ann Liebert, Inc.). p. 14.
  12.  http://www.takeda.com/press/article_43116.html
  13.  Hirschler, Ben (May 25, 2012). “Farmacêutica Takeda comprará Multilab por até R$ 540 mi”Grupo Abril (in portuguese). Exame. Retrieved January 27, 2013.
  14.  “Locations | Worldwide | Takeda Pharmaceutical Company Limited”. Takedaism.com. Retrieved 2010-09-18.
  15.  “By Business | Worldwide | Takeda Pharmaceutical Company Limited”. Takedaism.com. Retrieved 2010-09-18.
  16.  “Annual Reports | Investor Information | Takeda Pharmaceutical Company Limited”. Takeda.com. Retrieved 2010-09-18.

Takeda Pharmaceutical Company Limited
Takeda-pharma 200x200.jpg
Native name 武田薬品工業株式会社
Type Public KK
Traded as
Industry Pharmaceuticals
Founded Doshomachi, Osaka, Japan (June 12, 1781)
Headquarters 1-1, Doshomachi Yonchome,Chuo-ku, Osaka, Japan
Key people Yasuchika Hasegawa (President & CEO)
Revenue Increase ¥1,557,267 million (FY2012)[* 1]
Operating income Decrease ¥122,505 million (FY 2012)[* 1]
Net income Increase ¥131,244 million (FY 2012)[* 1]
Total assets Increase ¥3,955,599 million (FY 2012)[* 1]
Total equity Increase ¥2,223,359 million (FY 2012)[* 1]
Employees 30,481 (2012)
Website takeda.com (Global website)
References:

  1. “Financial Results for Fiscal 2012” (PDF). Takeda Pharmaceutical Company Limited. May 9, 2013. Retrieved June 13, 2013.

CMC CENTRE

The Chemistry, Manufacturing and Controls (CMC) Center is a global organization responsible for overall R&D activities ranging from chemical information on development candidates to the processes leading to “manufacturing” of pharmaceutical products.

The main sites are located in Osaka and consist of the following laboratories: the Chemical Development Laboratories in charge of R&D for developing the manufacturing methods of active pharmaceutical ingredients and the manufacturing of drug substances for clinical samples; the Pharmaceutical Technology R&D Laboratories in charge of R&D for dosage forms, manufacturing and packaging, as well as manufacturing of clinical samples; and the Analytical Development Laboratories in charge of R&D for the development of analytical methods and stability studies of clinical samples. In addition, Hikari Bio-Manufacturing Technology Laboratories is located in Hikari (Yamaguchi) and this is where antibody drug substances are manufactured.

As for overseas sites, the Cambridge Biologics CMC Group (Massachusetts) and the Chicago Pharmaceutical Science Group (Illinois) are located in the USA, while the CMC Center Europe is mainly located in Roskilde, Denmark. All research and development activities at Takeda are promoted with the cooperation of these sites.

List of Publications of Takeda Research Laboratories

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