LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 3Symbiotec Pharmalab
03 13M Drug Delivery Systems
04 1ASG Biochem
05 1Arudavis Labs
06 1Balaji Corporation
07 4Bayer AG
08 1CHEMO
09 1Cipla
10 1FORTEQ NIDAU AG
11 1Formosa Laboratories
12 3Gedeon Richter
13 1Guangzhou Tosun Pharmaceutical
14 1Hangzhou Longshine Bio-Tech
15 1Hubei Gedian Humanwell Pharmaceutical
16 1Hunan KYX Pharmaceutical
17 1Indo Phyto Chemicals Private Ltd
18 1Industriale Chimica
19 1Jenapharm GmbH & Co KG DE 07745 Jena
20 1Jiangsu Lianhuan Pharmaceutical
21 2Lupin Ltd
22 1Naari
23 3Qinhuangdao Zizhu Pharmaceutical
24 2ScinoPharm Taiwan, Ltd
25 2Sterling Spa
26 2Swati Spentose
27 1Yangzhou Pharmaceutical Factory
28 5Blank
01 9China
02 5Germany
03 3Hungary
04 13India
05 3Italy
06 1Spain
07 1Switzerland
08 3Taiwan
09 2U.S.A
10 5Blank
01 18Active
02 10Inactive
03 17Blank
01 9Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
04 34Blank
01 1218MF10828
02 1221MF10183
03 1221MF10292
04 1228MF10159
05 41Blank
01 1HB230032
02 1WC-0161A2
03 2WC-0162A2
04 1WC-0297
05 1WC-297
06 39Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2014-01-23
DMF Number : 27867
Submission : 2014-01-27
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0047
Start Marketing Date : 2017-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0047
Start Marketing Date : 2017-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0047
Start Marketing Date : 2017-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21547
Submission : 2008-07-03
Status : Active
Type : II
NDC Package Code : 53104-7669
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-15
Pay. Date : 2014-01-03
DMF Number : 17067
Submission : 2003-12-31
Status : Active
Type : II
Registration Number : 221MF10292
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144 Taiwan
Initial Date of Registration : 2009-12-25
Latest Date of Registration : --
NDC Package Code : 65129-2003
Start Marketing Date : 2003-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8806
Submission : 1990-10-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-141 - Rev 04
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9136
Submission : 1991-05-20
Status : Active
Type : II
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35419
Submission : 2020-12-16
Status : Active
Type : II
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14923
Submission : 2000-06-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-25
Pay. Date : 2014-08-13
DMF Number : 28502
Submission : 2014-08-05
Status : Active
Type : II
Certificate Number : R0-CEP 2021-255 - Rev 01
Issue Date : 2023-06-16
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 64918-1907
Start Marketing Date : 2021-04-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-28
Pay. Date : 2013-01-08
DMF Number : 4178
Submission : 1981-05-21
Status : Active
Type : II
Certificate Number : R1-CEP 2000-101 - Rev 03
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 926
Status : Valid
Registration Number : 218MF10828
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2006-10-20
Latest Date of Registration : --
NDC Package Code : 12866-1010
Start Marketing Date : 2017-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17307
Submission : 2004-04-16
Status : Active
Type : II
NDC Package Code : 12866-1010
Start Marketing Date : 2017-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-12-03
DMF Number : 21634
Submission : 2008-05-20
Status : Active
Type : II
Registration Number : 228MF10159
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2016-08-10
Latest Date of Registration : --
NDC Package Code : 66499-0018
Start Marketing Date : 2013-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-23
Pay. Date : 2013-07-16
DMF Number : 22508
Submission : 2009-03-31
Status : Active
Type : II
Certificate Number : CEP 2012-349 - Rev 01
Issue Date : 2024-09-13
Type : Chemical
Substance Number : 926
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-11-04
Pay. Date : 2024-10-30
DMF Number : 23612
Submission : 2011-03-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 16696
Submission : 2003-07-07
Status : Active
Type : II
Certificate Number : CEP 2003-127 - Rev 03
Issue Date : 2024-08-01
Type : Chemical
Substance Number : 926
Status : Valid
Registration Number : 221MF10183
Registrant's Address : Via E. H. Grieg, 13, 21047 Saronno (Varese) ITALY
Initial Date of Registration : 2009-08-13
Latest Date of Registration : --
NDC Package Code : 63190-0130
Start Marketing Date : 2003-11-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27692
Submission : 2013-10-20
Status : Active
Type : II
Certificate Number : R1-CEP 2013-237 - Rev 00
Issue Date : 2019-04-30
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 44132-004
Start Marketing Date : 2012-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26830
Submission : 2013-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37443
Submission : 2022-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17068
Submission : 2003-12-31
Status : Inactive
Type : II
NDC Package Code : 65129-2003
Start Marketing Date : 2003-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5156
Submission : 1983-09-22
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6175
Submission : 1986-01-27
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6225
Submission : 1986-02-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12994
Submission : 1998-05-18
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14288
Submission : 1999-07-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10218
Submission : 1993-05-04
Status : Inactive
Type : II
NDC Package Code : 12866-1010
Start Marketing Date : 2017-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18403
Submission : 2005-06-02
Status : Inactive
Type : II
NDC Package Code : 12866-1010
Start Marketing Date : 2017-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12934
Submission : 1998-03-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26064
Submission : 2012-05-19
Status : Inactive
Type : II
Date of Issue : 2018-11-05
Valid Till : 2021-11-04
Written Confirmation Number : WC-297
Address of the Firm :
A Levonorgestrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levonorgestrel, including repackagers and relabelers. The FDA regulates Levonorgestrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levonorgestrel API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Levonorgestrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levonorgestrel supplier is an individual or a company that provides Levonorgestrel active pharmaceutical ingredient (API) or Levonorgestrel finished formulations upon request. The Levonorgestrel suppliers may include Levonorgestrel API manufacturers, exporters, distributors and traders.
click here to find a list of Levonorgestrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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