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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Bidachem S.p.a.

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Ambroxol hydrochloride

Bisacodyl

Bisacodyl Powder

Bromhexine hydrochloride

CHLORTHALIDONE U.S.P.

CROTAMITON

KETOPROFEN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES

MELOXICAM

METHOCARBAMOL

Orciprenaline sulfate

RIBAVIRIN

Sodium picosulfate

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Status - Active

Status - Inactive

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VALID

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218MF10395

220MF10085

220MF10132

221MF10127

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ambroxol hydrochloride
Issue/Submission Date
2011-02-10
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Ambroxol hydrochloride at S. S. 11 ...
Issue/Submission Date
2008-03-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Ambroxol hydrochloride
Ambroxol hydrochloride at S. S. 11 ...
Issue/Submission Date
2011-02-10
2008-03-18
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bisacodyl Powder
Issue/Submission Date
2010-01-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Bisacodyl Powder
Issue/Submission Date
2010-01-07
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bisacodyl
Issue/Submission Date
2010-01-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Bisacodyl
Issue/Submission Date
2010-01-07
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bromhexine hydrochloride
Issue/Submission Date
2015-12-14
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Bromhexine hydrochloride
Issue/Submission Date
2015-12-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CHLORTHALIDONE U.S.P.
Issue/Submission Date
1982-06-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CHLORTHALIDONE U.S.P.
Issue/Submission Date
1982-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CROTAMITON
Issue/Submission Date
2001-02-08
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Crotamiton
Issue/Submission Date
2012-05-11
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Crotamiton at S. S. 11 Padana Super...
Issue/Submission Date
2009-06-23
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CROTAMITON
Crotamiton
Crotamiton at S. S. 11 Padana Super...
Issue/Submission Date
2001-02-08
2012-05-11
2009-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
KETOPROFEN
Issue/Submission Date
2005-02-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ketoprofen
Issue/Submission Date
2010-07-08
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Ketoprofen at S. S. 11 Padana Super...
Issue/Submission Date
2006-03-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
KETOPROFEN
Ketoprofen
Ketoprofen at S. S. 11 Padana Super...
Issue/Submission Date
2005-02-21
2010-07-08
2006-03-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MELOXICAM
Issue/Submission Date
1998-10-29
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MELOXICAM
Issue/Submission Date
1998-10-29
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
METHOCARBAMOL
Issue/Submission Date
2000-05-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
METHOCARBAMOL
Issue/Submission Date
2000-05-31
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Orciprenaline sulfate
Issue/Submission Date
2012-03-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Orciprenaline sulfate
Issue/Submission Date
2012-03-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
RIBAVIRIN
Issue/Submission Date
2001-10-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
RIBAVIRIN
Issue/Submission Date
2001-10-01
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Sodium picosulfate
Issue/Submission Date
2009-11-04
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Picosulfate sodium hydrate at S. S....
Issue/Submission Date
2008-05-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Sodium picosulfate
Picosulfate sodium hydrate at S. S....
Issue/Submission Date
2009-11-04
2008-05-20
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1980-06-18
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1980-06-18
Supporting Info

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