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List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Shiratori Pharmaceutical to the Review Authority in Japan (PMDA). Original Data : PMDA

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01 Azelnidipine production dedicated (1)

02 Bortezomib production dedicated (1)

03 Bortezomib production only (1)

04 Bosentan hydrate production-only (1)

05 Dedicated for manufacturing solifenacin succinate (1)

06 Dedicated to the production of palonosetron hydrochloride (1)

07 Dedicated to tolvaptan production (1)

08 Dochinrad manufacturing only (1)

09 Gimeracil production dedicated (1)

10 Hydrochloric acid Pilsicainide (1)

11 Japanese Pharmacopoeia fumaric acid emedastin production dedicated (1)

12 Japanese Pharmacopoeia hydrochloric acid dobutamine production dedicated (1)

13 Japanese Pharmacopoeia hydrochloric acid noscapine production dedicated (1)

14 Japanese Pharmacopoeia theophylline production dedicated (1)

15 Methylprednisolone sodium succinate (1)

16 Nemonapride production dedicated (1)

17 Olanzapine production dedicated (1)

18 Only the Japanese Pharmacopoeia anhydrous caffeine production (1)

19 Only the Japanese Pharmacopoeia noscapine production (1)

20 Oteracil potassium production dedicated (1)

21 Pimobendan production dedicated (1)

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01 Shiratori Pharmaceutical Co., Ltd. (21)

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01 Japan (7)

02 U.S.A (14)

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Shiratori Pharmaceutical ...
2012-02-23
2012-02-23
224MF10038
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2017-07-31
2017-07-31
229MF10148
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2019-10-29
2019-10-29
301MF10086
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2016-05-09
2015-08-03
227MF10189
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2019-11-19
2019-11-19
301MF10095
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2020-01-24
2020-01-24
302MF10012
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2020-11-04
2020-11-04
302MF10134
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2018-10-01
2018-10-01
230MF10137
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2016-04-22
2012-02-23
224MF10037
6-11-24 Tsudanuma, Narash...
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Shiratori Pharmaceutical ...
2008-03-14
2005-07-14
217MF10321
6-11-24 Tsudanuma, Narash...
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