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

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01 Amlodipine besylate (1)

02 Amorphous atorvastatin calcium (1)

03 Ampicillin sodium (sterile) (1)

04 Bae Lind erbumine (1)

05 Dutasteride (1)

06 Eletriptan hydrobromide (1)

07 Entacapone (1)

08 Ethyl-3,5,6-tri-O-benzyl-D-glucofuranoside (1)

09 Finasteride (1)

10 Hydrochlorothiazide (1)

11 Japanese Pharmacopoeia atorvastatin calcium hydrate (1)

12 Japanese Pharmacopoeia domperidone (1)

13 Japanese Pharmacopoeia irbesartan (1)

14 Japanese Pharmacopoeia olmesartan medoxomil (1)

15 Japanese Pharmacopoeia piperacillin hydrate (1)

16 Japanese Pharmacopoeia tazobactam (1)

17 Japanese Pharmacopoeia valsartan (2)

18 Lamotrigine (1)

19 Levofloxacin hydrate (1)

20 Losartan potassium (1)

21 Nateglinide (1)

22 Olanzapine (1)

23 Piperacillin hydrate (production only) (1)

24 Pivmecillinam hydrochloride (1)

25 Pramipexole hydrochloride hydrate (1)

26 Raloxifene hydrochloride (1)

27 Rivastigmine (1)

28 Sertraline hydrochloride (1)

29 Tazobactam (production only) (1)

30 Terbinafine hydrochloride (1)

31 Valacyclovir hydrochloride hydrate (1)

32 Valsartan (1)

33 Zolmitriptan (1)

34 esomeprazole magnesium hydrate (1)

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01 Aurobindo Pharma Limited (35)

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01 India (35)

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Aurobindo Pharma Limited
2014-03-06
2014-03-06
226MF10061
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Aurobindo Pharma Limited
2011-07-15
2011-07-15
223MF10105
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Aurobindo Pharma Limited
2020-02-06
2020-02-06
302MF10023
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Aurobindo Pharma Limited
2015-01-05
2015-01-05
227MF10018
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Aurobindo Pharma Limited
2019-03-04
2019-03-04
231MF10062
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Aurobindo Pharma Limited
2017-09-04
2017-09-04
229MF10175
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Aurobindo Pharma Limited
2015-11-20
2015-01-23
227MF10029
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Aurobindo Pharma Limited
2021-08-20
2021-08-20
303MF10137
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Aurobindo Pharma Limited
2015-03-12
2015-03-12
227MF10068
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Aurobindo Pharma Limited
2015-03-12
2015-03-12
227MF10088
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