Generic Drug, API & DMF

關西地區的製藥業

2011-04-07T17:26:00.000+08:00

TFDA Review 2011.1.17《食品藥物管理局藥品藥政業務之回顧與展望說明會之講義內容》

2011-01-20T11:23:00.000+08:00

鄒組長-我國藥品藥政改革策略及將來審查新制說明
一科-藥品安全評估業務
二科-新化學藥品審查業務之回顧與展望
三科-學名藥品審查業務之回顧與展望
四科-生物藥品及新興生技藥品審查業務之回顧與展望
五科-藥品臨床試驗業務成果與展望
六科-1-藥事人員繼續教育
六科-2-藥師管理與藥事服務業務回顧與展望

CPhI WW 2010 Paris：　Étude Op. 10, No. 12, Revolutionary

2010-10-07T04:16:00.004+08:00

ＣＰｈＩでショパンの練習曲第12番ハ短調：「革命」

Japan GMP 2007 (108 pages)

2010-09-27T09:55:00.002+08:00

1. 変更管理システムに関する提言;
2. Science and Regulatory Studies at National Institute of Health Sciences;
3. Current Japanese Regulations and Implementation of ICH Q8-Q10;

CPHI Worldwide 2010

2010-05-10T09:07:00.000+08:00

The CPHI event was first held in 1990 and 2010 marks the 21st year of this prominent and industry-leading occasion. From just 250 delegates at the initial convention, visitor numbers have steadily grown from more than a few hundred visitors to well over 25,000 people. Hosting over 1,400 exhibitors, the event now covers more than 50,000 square meters of exposition space. Regarding global pharmaceuticals ingredients, it is the main promotion leader in the industry.

This important event gives customers of the industry a chance to meet various manufacturers and discuss their products. Medicine has come a long way and the world is learning more each day. Medical professionals today have the privilege of being able to make the best choices and feel confident in making decisions regarding drugs.

There are many reasons to attend the CPHI Worldwide Event, of course, but it helps to know that visitors from over 125 countries will be attending and this creates a matchless environment where delegates can gather, study, and share thoughts with each other. The wide-range of exhibitors allows visitors to renew existing acquaintances as well as establish new marketable associations. Every year, over 95% of visitors make new business acquaintances and leads. With both recognized businesses and new participants exhibiting, visitors have access to key pharmaceutical ingredients represented by professionals from around the globe, as well as fast-moving and emerging new markets. CPHI includes a conference agenda, speaker’s area, an industry awards presentation and a series of specialist events.

http://www.cphi.com/

Visit to India Companies

2010-04-20T13:34:00.001+08:00

来週インドの製薬会社へ

TFDA Chief speech TFDA局長康照洲 (mp3)

2010-04-19T13:56:00.001+08:00

2010.4.15

http://twaud.io/SVM

兩岸醫藥交流自去年10月由國家生技醫療產業策進會率團拜會大陸衛生部後，雙方都期待在今年的江陳會能簽署實質醫藥協議，為了這項共識，衛生署藥物食品管理局（TFDA）局長康照洲已計劃4月底拜會大陸國家食品藥品監督管理局（SFDA）局長邵明立。

Ranbaxy, Pfenex ties up for Biosimilar Therapeutic development

2010-03-31T10:39:00.001+08:00

インドの製薬最大手ランバクシー・ラボラトリーズ(500359.BY)は29日、バイオシミラーの治療用タンパク質を米フィーネックス（Pfenex、本社：カリフォルニア州）と共同で開発する契約を締結したと発表した。

Ranbaxy Laboratories Limited and Pfenex Inc. announced that Ranbaxy will develop an undisclosed biosimilar therapeutic produced in the Pfēnex Expression Technology™ platform, a Pseudomonas-based recombinant protein expression technology.

http://www.indiainfoline.com/Markets/News/Ranbaxy-Pfenex-ties-up-for-Biosimilar-Therapeutic-development/4804638377

Fire Burns Savior Lifetec Factory, Causing $7Mln Loss

2010-03-31T09:43:00.006+08:00

カルバペネム系抗生物質メーカーが火事

Savior Lifetec is a Taiwanese manufacturer of carbapenem antibiotics. The fire in the morning of Mar 30th caused USD 7 million loss.

火事写真

【聯合報╱記者胡蓬生／竹南報導】

苗栗縣竹南科學園區展旺生命科技公司，昨天上午發生火警，大火延燒逾2小時，不斷發生爆炸，巨大火球和濃煙直竄，火勢在10時後逐漸控制，這起火災是竹南園區成立近10年來最嚴重的，廠商損失估計超過2億元以上，但實際財務損失，展旺仍估算中。苗栗縣消防局今天到火場鑑識，調查火警原因。

News in Chinese

The First 2 Biosimilars (Follow on Biologicals) in Japan

2010-03-30T08:54:00.006+08:00

Please refer to the new Regulation on Biosimilar in Mar 2009. (Japanese)

There are 2 products in the market now:

1. The first biosimilar in Japan was Sandoz' Somatropin BS. (English news)

The Novartis generics business, Sandoz, launched its recombinant human growth hormone somatropin, Somatropin BS S.C., in Japan. The company says the drug is the first ever biosimilar to be approved and launched in that country, which represents the world’s second largest pharma market.

2. Nippon Chemical Research's EPO was the second biosimilar approved in Japan. (2010 Jan)

Reference:
バイオ後続品の品質・安全性・有効性確保のための指針

バイオ後続品について

質疑応答集　（2010.3.31）

Biosimilars approval status worldwide

動き出すバイオ後続品市場

学術 Q&A Q バイオ後続品とは何ですか

日欧米三極におけるＧＭＰ【システム】査察とGMP体制の違い

2010-03-26T10:51:00.003+08:00

It has been my interest to know the difference of GMP systems among USA, EU and Japan.

According to Mr Yasumoto:

" The impression was that PMDA (Japanese authorities) is not as demanding as FDA. However, PMDA seems to be very strict for biopharmaceuticals and analytical procedures. PIC/s is similar to WHO and FDA, while some particular analytical methods are required."

@Asian_API 日本のPMDAはFDAのシステム査察よりは甘い印象がある反面、バイオ医薬や試験法には非常に厳格なイメージがあります。PIC/SはWHOとFDAとほぼ同じですが、一部独自の試験法が要求されている感じ。でしょうか？140字だとなかなか説明は難しいですね。less than a minute ago via HootSuiteAtsushi Yasumoto
Atsu_4

参考：FDAとEMEAの相違点　査察官特別講演ｐ４８

In EU, Germany has special regulation for biological /fermentation products while other European countries don't. Still, fermentation products like statins or immunosuppressants are not as difficult as protein drugs.

Taiyo Pharmaceutical Plant to be shutdown for 10 days

2010-03-18T14:54:00.004+08:00

大洋薬品高山工場

28,500 cartons of Famotidine 20mg were delivered in April~Sep 2009. But the assay was OOS.

The government ruled that operaton of Takayam plant should be held for 10 days from Mar 26th.

http://www.yakuji.co.jp/entry18556.html

高山工場見学

APIs Export More than Dosages in 2009

2010-03-15T10:26:00.002+08:00

The news from Taiwan

我國原料藥出口值高於西藥製劑

【經濟日報╱記者謝柏宏／即時報導】

2010.02.26 11:21 pm

ITIS公布98年第四季及全年製藥產業發展，原料藥出口值高於西藥製劑。

ITIS指出，歷年來我國製藥產業的出口多以西藥製劑為主，但2008年原料藥的出口值已超越了西藥製劑，使得我國原料藥開始呈現貿易順差。

推估2009年全年我國原料藥的出口較2008年同期成長6.8%，為新台幣51.9億元；反觀西藥製劑，則一直呈現貿易逆差，2009年全年出口值為新台幣48.6億元。

【2010/02/26 經濟日報】@ http://udn.com/

Taiyo's commercial to promote Generics

2010-02-23T11:41:00.001+08:00

Taiwan biotech: FDA - Taiwanese-style

2009-12-29T10:39:00.002+08:00

FDA change process 2003

2009-12-14T15:54:00.001+08:00

Pdf file

Taiwan GMP inspection (Chinese)

2009-10-07T09:35:00.003+08:00

PIC/S & Taiwan

Taiwan GMP inspection

Meeting minute on DMF instroduction 2009 April

Opening the door for biogenerics

2009-09-22T15:14:00.001+08:00

http://washingtontimes.com/news/2009/sep/18/opening-the-door-for-biogenerics/

Chinese

Novartis hits Astellas with generic Prograf

2009-08-12T10:26:00.007+08:00

アステラス製薬の免疫抑制剤・Prograf（tacrolimus）のジェネリックをSandozがアメリカで発売したと発表しました。

http://mainichi.jp/life/money/kabu/nsj/news/20090812171823.html

ひとつのtacrolimus原薬メーカーは台湾のＣＣＳＢです。

Prograf has 3 strengths: 0.5 mg, 1 mg and 5 mg. Sandoz ANDA number is 065461

TOKYO, Aug 11 (Reuters) - Swiss drugmaker Novartis AG said on Tuesday it had launched a generic version of Astellas Pharma Inc's transplant drug Prograf, its biggest drug by revenue, helping send shares of the Japanese drugmaker 5 percent lower.

http://www.forbes.com/feeds/afx/2009/08/11/afx6763956.html

The two major Asian API suppliers are Biocon and CCSB.