LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise. LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise.

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

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Janssen Pharmaceutical
United_States_of_America Flag
Country
Country
U.S.A
Address
Address
1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560
Telephone
Telephone
+1-800-775-5514.
Linkedin
Linkedin
Twitter
Twitter

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USDMF

Caution USDMF

5402
Inactive
DOMPERIDONE (RESEARCH CODE R-33812)
1984-05-17
CEP/COS

Found CEP/COS

R1-CEP 1996-069 - Rev 10
Valid
Domperidone
2019-10-22
Japanese DMF

Found JDMF

218MF10687
Domperidone at Turnhoutsweg 30 B-23...
2006-08-11
Written Confirmation

Close WC

Application Number
5402
218MF10687
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
DOMPERIDONE (RESEARCH CODE R-33812)
Domperidone
Domperidone at Turnhoutsweg 30 B-23...
Issue/Submission Date
1984-05-17
2019-10-22
2006-08-11
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USDMF

Caution USDMF

5847
Inactive
LEVOCABASTINE HCL.(BULK)
1985-04-19
CEP/COS

Found CEP/COS

R1-CEP 2002-147 - Rev 03
Valid
Levocabastine hydrochloride
2020-12-09
Japanese DMF

Found JDMF

228MF10206
Levocabastine hydrochloride at Turn...
2016-11-02
Written Confirmation

Close WC

Application Number
5847
228MF10206
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
LEVOCABASTINE HCL.(BULK)
Levocabastine hydrochloride
Levocabastine hydrochloride at Turn...
Issue/Submission Date
1985-04-19
2020-12-09
2016-11-02
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USDMF

Caution USDMF

10912
Inactive
MICONAZOLE DRUG SUBSTANCE
1994-05-20
CEP/COS

Found CEP/COS

R2-CEP 1995-007 - Rev 03
Valid
Miconazole
2014-11-14
Japanese DMF

Found JDMF

219MF10165
Miconazole at Turnhoutsweg 30 B-234...
2007-05-21
Written Confirmation

Close WC

Application Number
10912
219MF10165
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
MICONAZOLE DRUG SUBSTANCE
Miconazole
Miconazole at Turnhoutsweg 30 B-234...
Issue/Submission Date
1994-05-20
2014-11-14
2007-05-21
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USDMF

Caution USDMF

10913
Inactive
MICONAZOLE NITRATE DRUG SUBSTANCE
1994-05-20
CEP/COS

Found CEP/COS

R2-CEP 1995-008 - Rev 04
Valid
Miconazole nitrate
2023-03-01
Japanese DMF

Found JDMF

219MF10167
Miconazole nitrate at Turnhoutsweg ...
2007-05-21
Written Confirmation

Close WC

Application Number
10913
219MF10167
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
MICONAZOLE NITRATE DRUG SUBSTANCE
Miconazole nitrate
Miconazole nitrate at Turnhoutsweg ...
Issue/Submission Date
1994-05-20
2023-03-01
2007-05-21
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USDMF

Found USDMF

10946
Active
HALOPERIDOL (R001625) DRUG SUBSTANC...
1994-06-13
CEP/COS

Found CEP/COS

R1-CEP 1998-076 - Rev 09
Valid
Haloperidol
2014-06-05
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10946
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
HALOPERIDOL (R001625) DRUG SUBSTANC...
Haloperidol
Issue/Submission Date
1994-06-13
2014-06-05
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USDMF

Found USDMF

10954
Active
HALOPERIDOL DECANOATE
1994-06-23
CEP/COS

Found CEP/COS

R1-CEP 2002-187 - Rev 04
Valid
Haloperidol decanoate
2014-06-12
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10954
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
HALOPERIDOL DECANOATE
Haloperidol decanoate
Issue/Submission Date
1994-06-23
2014-06-12
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USDMF

Found USDMF

10725
Active
ITRACONAZOLE (R051211) DRUG SUBSTAN...
1994-02-18
CEP/COS

Found CEP/COS

R1-CEP 1999-092 - Rev 07
Valid
Itraconazole Method 1
2017-02-07
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10725
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ITRACONAZOLE (R051211) DRUG SUBSTAN...
Itraconazole Method 1
Issue/Submission Date
1994-02-18
2017-02-07
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USDMF

Found USDMF

10037
Active
KETOCONAZOLE DRUG SUBSTANCE
1993-01-15
CEP/COS

Found CEP/COS

R2-CEP 1995-009 - Rev 04
Valid
Ketoconazole
2021-03-08
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10037
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
KETOCONAZOLE DRUG SUBSTANCE
Ketoconazole
Issue/Submission Date
1993-01-15
2021-03-08
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USDMF

Found USDMF

23824
Active
RILPIVIRINE HYDROCHLORIDE (R314585)...
2010-07-19
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

229MF10183
Rirupibirin hydrochloride at Little...
2017-10-06
Written Confirmation

Close WC

Application Number
23824
229MF10183
Status
Active
Fees Paid
Reviewed
 
Filing Details
RILPIVIRINE HYDROCHLORIDE (R314585)...
Rirupibirin hydrochloride at Little...
Issue/Submission Date
2010-07-19
2017-10-06
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USDMF

Found USDMF

11438
Active
RISPERIDONE (R064766) DRUG SUBSTANC...
1995-04-11
CEP/COS

Found CEP/COS

R1-CEP 2001-183 - Rev 05
Valid
Risperidone
2017-01-10
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11438
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
RISPERIDONE (R064766) DRUG SUBSTANC...
Risperidone
Issue/Submission Date
1995-04-11
2017-01-10
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USDMF

Found USDMF

10919
Active
TOPIRAMATE DRUG SUBSTANCE
1994-05-27
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

220MF10001
Topiramate at 1440 Olympic Drive, A...
2008-01-09
Written Confirmation

Close WC

Application Number
10919
220MF10001
Status
Active
Fees Paid
N/A
 
Filing Details
TOPIRAMATE DRUG SUBSTANCE
Topiramate at 1440 Olympic Drive, A...
Issue/Submission Date
1994-05-27
2008-01-09
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USDMF

Caution USDMF

11337
Inactive
ALFENTANIL HYDROCHLORIDE
1995-02-03
CEP/COS

Found CEP/COS

R1-CEP 1997-086 - Rev 03
Valid
Alfentanil hydrochloride hydrate
2016-09-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11337