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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ambiopharm, Inc.

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BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE

EPTIFIBATIDE (NON-STERILE, BULK DRUG SUBSTANCE)

GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE

GLUCAGON, NON-STERILE, BULK DRUG SUBSTANCE

ICATIBANT ACETATE (NON-STERILE)

LEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE

LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE

OCTREOTIDE, NON-STERILE, BULK DRUG SUBSTANCE

TEDUGLUTIDE NON-STERILE

TERIPARATIDE USP (ACETATE FORM)

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BIVALIRUDIN, NON-STERILE BULK DRUG ...
Issue/Submission Date
2007-09-14
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
BIVALIRUDIN, NON-STERILE BULK DRUG ...
Issue/Submission Date
2007-09-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
EPTIFIBATIDE (NON-STERILE, BULK DRU...
Issue/Submission Date
2011-04-18
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
EPTIFIBATIDE (NON-STERILE, BULK DRU...
Issue/Submission Date
2011-04-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
GLATIRAMER NON-STERILE, BULK DRUG S...
Issue/Submission Date
2012-09-27
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
GLATIRAMER NON-STERILE, BULK DRUG S...
Issue/Submission Date
2012-09-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GLUCAGON, NON-STERILE, BULK DRUG SU...
Issue/Submission Date
2012-08-21
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
GLUCAGON, NON-STERILE, BULK DRUG SU...
Issue/Submission Date
2012-08-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ICATIBANT ACETATE (NON-STERILE)
Issue/Submission Date
2015-05-22
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
ICATIBANT ACETATE (NON-STERILE)
Issue/Submission Date
2015-05-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LEUPROLIDE, NON-STERILE, BULK DRUG ...
Issue/Submission Date
2012-09-05
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
LEUPROLIDE, NON-STERILE, BULK DRUG ...
Issue/Submission Date
2012-09-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LIRAGLUTIDE, NON-STERILE, BULK DRUG...
Issue/Submission Date
2013-06-12
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
LIRAGLUTIDE, NON-STERILE, BULK DRUG...
Issue/Submission Date
2013-06-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
OCTREOTIDE, NON-STERILE, BULK DRUG ...
Issue/Submission Date
2013-11-21
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
OCTREOTIDE, NON-STERILE, BULK DRUG ...
Issue/Submission Date
2013-11-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TEDUGLUTIDE NON-STERILE
Issue/Submission Date
2016-08-12
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
TEDUGLUTIDE NON-STERILE
Issue/Submission Date
2016-08-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TERIPARATIDE USP (ACETATE FORM)
Issue/Submission Date
2017-06-01
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
TERIPARATIDE USP (ACETATE FORM)
Issue/Submission Date
2017-06-01
Supporting Info

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