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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured

REGULATORY FILINGS

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Alpha-Cyclodextrin

Aluminum Magnesium Silicate

Beta-Cyclodextrin

Beta-Cyclodextrin API

Calcium Acid Phosphate

Calcium Stearate API

Carboxymethylcellulose Sodium

Cetostearyl Alcohol

Crospovidone

Dextrose Monohydrate

Dihexadecanoyl Phosphatidylcholine

Dimyristoyllecithin

Dimyristoylphosphatidylglycerol

Distearoyl Phosphatidyl Glycerol Sodium Salt

Eudragits

Gamma-Cyclodextrin

Glycerol, Unmodified

Hard Capsule

Hydroxyethyl Acrylate

Hydroxypropyl Betacyclodextrin

Hydroxypropyl Cellulose

Hydroxypropyl-Beta Cyclodextrin

Hypromellose

Hypromellose Acetate Succinate

Hypromellose Phthalate

Kappa-Carrageenan

Lanolin Alcohol

Levomenthol

Macrogol 15 Hydroxystearate

Magnesium Stearate

Maltodextrin API

Mannide Monooleate

Mannitol

Medium Chain Triglycerides

Microcrystalline Cellulose

Mpeg5000 dppe

PEG-30 Dipolyhydroxy Stearate

Polyethylene Glycol

Polysorbate 80

Polyvinyl Alcohol

Povidone

Propylene Glycol

Safinamide Mesylate

Sepitrap 4000

Silicon Dioxide API

Sodium Hyaluronate

Sodium Stearyl Fumarate API

Sorbitan Monolaurate

Sorbitol

Sorbitol API

Starch, Corn

Stearic Acid

Sucralose Excipient

Sucrose API

Sulfobutylether-β-Cydodextrin (SBECD)

Tartaric Acid

Tetrahydrocannabinol

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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217MF10324

217MF10328

217MF11171

217MF40003

220MF20001

221MF10096

221MF10102

222MF10150

222MF10152

223MF20002

228MF10141

229MF10139

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WC-0187

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USDMF

Found

Application Number
21266
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
SEPINEO™ P 600
Issue/Submission Date
2008-01-18
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
21266
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
SEPINEO™ P 600
Issue/Submission Date
2008-01-18
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USDMF

Caution

Application Number
1115
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AEROSIL
Issue/Submission Date
1967-12-28
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
1115
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AEROSIL
Issue/Submission Date
1967-12-28
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USDMF

Found

Application Number
14937
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ALPHA-CYCLODEXTRIN.A DRUG SUBSTANCE...
Issue/Submission Date
2000-06-20
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
14937
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ALPHA-CYCLODEXTRIN.A DRUG SUBSTANCE...
Issue/Submission Date
2000-06-20
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USDMF

Found

Application Number
12893
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
NEUSILIN MAGNESIUM ALUMINOMETASILIC...
Issue/Submission Date
1998-03-09
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Found

Application Number
221MF10096
Status
 
Filing Details
Magnesium aluminometasilicate (S1) ...
Issue/Submission Date
2009-05-13
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
12893
221MF10096
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
NEUSILIN MAGNESIUM ALUMINOMETASILIC...
Magnesium aluminometasilicate (S1) ...
Issue/Submission Date
1998-03-09
2009-05-13
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USDMF

Found

Application Number
26315
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
VEEGUM; NATIONAL FORMULARY GRADES
Issue/Submission Date
2012-08-10
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
26315
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
VEEGUM; NATIONAL FORMULARY GRADES
Issue/Submission Date
2012-08-10
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USDMF

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

Found

Application Number
Status
VALID
Filing Details
Betadex
Issue/Submission Date
2017-02-13
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
VALID
 
Filing Details
Betadex
Issue/Submission Date
2017-02-13
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USDMF

Found

Application Number
14620
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BETA-CYCLODEXTRIN
Issue/Submission Date
1999-12-08
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
14620
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
BETA-CYCLODEXTRIN
Issue/Submission Date
1999-12-08
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USDMF

Found

Application Number
15489
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
METHYL BETA-CYCLODEXTRIN
Issue/Submission Date
2001-06-15
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
15489
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
METHYL BETA-CYCLODEXTRIN
Issue/Submission Date
2001-06-15
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USDMF

Found

Application Number
12692
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
FUJICALIN
Issue/Submission Date
1997-10-08
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
12692
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
FUJICALIN
Issue/Submission Date
1997-10-08
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USDMF

Caution

Application Number
27262
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CALCIUM STEARATE USP/NF
Issue/Submission Date
2013-06-21
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
27262
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CALCIUM STEARATE USP/NF
Issue/Submission Date
2013-06-21
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USDMF

Found

Application Number
12787
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CROSCARMELLOSE SODIUM NF (PROCESS I...
Issue/Submission Date
1997-12-09
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Croscarmellose sodium Process II
Issue/Submission Date
2019-09-18
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
12787
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
VALID
 
Filing Details
CROSCARMELLOSE SODIUM NF (PROCESS I...
Croscarmellose sodium Process II
Issue/Submission Date
1997-12-09
2019-09-18
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USDMF

Found

Application Number
24910
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CROSCARMELLOSE SODIUM NF (PROCESS I...
Issue/Submission Date
2011-01-12
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Croscarmellose sodium
Issue/Submission Date
2010-02-24
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
24910
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
VALID
 
Filing Details
CROSCARMELLOSE SODIUM NF (PROCESS I...
Croscarmellose sodium
Issue/Submission Date
2011-01-12
2010-02-24
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USDMF

Found

Application Number
18925
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
SEPINEO SE 68
Issue/Submission Date
2005-11-01
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
18925
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
SEPINEO SE 68
Issue/Submission Date
2005-11-01
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USDMF

Found

Application Number
29000
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
COPOVIDONE
Issue/Submission Date
2015-01-08
CEP/COS

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Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
29000
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
COPOVIDONE
Issue/Submission Date
2015-01-08
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USDMF

Found

Application Number
28972
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CROSPOVIDONE
Issue/Submission Date
2014-12-29
CEP/COS

Found

Application Number
Status
VALID
Filing Details
Crospovidone Type A and B
Issue/Submission Date
2017-05-02
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
28972
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
VALID
 
Filing Details
CROSPOVIDONE
Crospovidone Type A and B
Issue/Submission Date
2014-12-29
2017-05-02
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USDMF

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

Found

Application Number
Status
VALID
Filing Details
Crospovidone
Issue/Submission Date
2011-02-21
Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Application Number
Status
Filing Deta