LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1Cohance Lifesciences
03 1HRV Global Life Sciences
04 1Mankind Pharma
05 1Arevipharma
06 2Aurore Life Sciences
07 1Ax Pharmaceutical Corporation
08 1Cambrex Corporation
09 1Global Calcium
10 1Jiangsu Nhwa Pharmaceutical
11 1Jin Dun Medical
12 3Medichem S.A
13 1Medilux Laboratories
14 1Otto Brandes
15 1R L Fine Chem
16 1SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL
17 1SMS Pharmaceuticals
18 1Sandoz B2B
19 1Shouguang Fukang Pharmaceutical Co., Ltd
20 1Smilax Laboratories Limited
21 1Tianish Laboratories
22 1Viatris
23 1WUHAN SHIJI PHARMACEUTICAL CO LTD
24 1Wuhan Shiji Pharmaceutical
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01 1Canada
02 6China
03 2Germany
04 11India
05 3Spain
06 1Switzerland
07 3U.S.A
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01 12Active
02 4Inactive
03 13Blank
01 8Valid
02 2Withdrawn by Holder
03 19Blank
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01 1301MF10021
02 28Blank
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01 1WC-0015
02 1WC-0104
03 1WC-0119
04 1WC-0119A10
05 1WC-0195
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01 120180903-209-J-157
02 120180903-209-J-157(1)
03 120180903-209-J-157(2)
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01 112828-0072
02 153296-0033
03 164374-004
04 165015-706
05 167835-0028
06 171554-025
07 173377-150
08 176072-1010
09 184206-0023
10 20Blank
01 29Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-29
Pay. Date : 2018-12-07
DMF Number : 31999
Submission : 2017-08-24
Status : Active
Type : II
Certificate Number : R0-CEP 2018-192 - Rev 01
Issue Date : 2021-02-12
Type : Chemical
Substance Number : 1191
Status : Withdrawn by Holder
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1010
Start Marketing Date : 2017-06-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37540
Submission : 2023-02-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-29
Pay. Date : 2013-09-25
DMF Number : 25182
Submission : 2011-08-03
Status : Active
Type : II
Certificate Number : R1-CEP 2012-006 - Rev 00
Issue Date : 2018-04-12
Type : Chemical
Substance Number : 1191
Status : Valid
NDC Package Code : 64374-004
Start Marketing Date : 2016-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11195
Submission : 1994-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38071
Submission : 2023-03-09
Status : Active
Type : II
NDC Package Code : 71554-025
Start Marketing Date : 2021-01-08
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 : 19822
Submission : 2006-10-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-26
Pay. Date : 2022-12-12
DMF Number : 36645
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2021-110 - Rev 01
Issue Date : 2025-01-20
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11098
Submission : 1994-09-26
Status : Inactive
Type : II
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PharmaCompass offers a list of Clozapine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Clozapine manufacturer or Clozapine supplier for your needs.
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A Lapenax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lapenax, including repackagers and relabelers. The FDA regulates Lapenax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lapenax API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Lapenax supplier is an individual or a company that provides Lapenax active pharmaceutical ingredient (API) or Lapenax finished formulations upon request. The Lapenax suppliers may include Lapenax API manufacturers, exporters, distributors and traders.
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We have 24 companies offering Lapenax
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