PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
02 1AbbVie Inc
03 1LGM Pharma
04 1Gonane Pharma
05 1HRV Global Life Sciences
06 1Ajinomoto Company
07 1Amara Labs
08 1Amuna Pharmaceuticals
09 1Arene Lifesciences
10 2Aurobindo Pharma Limited
11 1Catalent Pharma Solutions
12 1Chromo Laboratories
13 1Cipla
14 1Curia
15 1Dalian Richon Chem
16 2Emcure Pharmaceuticals
17 1Guangzhou Tosun Pharmaceutical
18 1HEC Pharm
19 4Hetero Drugs
20 1Hiray Pharma Solutions
21 1Keminntek Laboratories
22 2Laurus Labs
23 3Lupin Ltd
24 1Olon S.p.A
25 1RANBAXY LABORATORIES LIMITED
26 1Raks Pharma
27 1SPC Lifesciences Pvt. Ltd
28 1Shanghai Desano Bio-Pharmaceutical
29 2Shanghai Desano Chemical Pharmaceutical Co., Ltd.
30 1Symed Labs
31 1Tecoland Corporation
32 2Tianish Laboratories
33 1Trimax Bio Sciences
34 2Viatris
01 7China
02 1France
03 27India
04 1Italy
05 1Japan
06 8U.S.A
01 16Active
02 8Inactive
03 21Blank
01 10Valid
02 1Withdrawn by Holder
03 34Blank
01 45Blank
01 1WC-0015
02 1WC-0049
03 1WC-0066
04 1WC-0113
05 1WC-0120
06 1WC-0120A4
07 1WC-0213
08 1WC-0226
09 1WC-0395A1
10 36Blank
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
Certificate Number : R1-CEP 2012-397 - Rev 00
Issue Date : 2019-09-19
Type : Chemical
Substance Number : 2136
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-19
DMF Number : 24383
Submission : 2010-12-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-30
DMF Number : 19800
Submission : 2006-09-26
Status : Active
Type : II
Certificate Number : R0-CEP 2014-209 - Rev 00
Issue Date : 2015-11-12
Type : Chemical
Substance Number : 2136
Status : Withdrawn by Holder
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-662
Start Marketing Date : 2015-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34846
Submission : 2020-05-03
Status : Active
Type : II
Certificate Number : CEP 2022-293 - Rev 00
Issue Date : 2024-01-03
Type : Chemical
Substance Number : 2136
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-03
Pay. Date : 2014-03-28
DMF Number : 28128
Submission : 2014-03-31
Status : Active
Type : II
NDC Package Code : 47621-035
Start Marketing Date : 2018-06-01
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 : 19839
Submission : 2006-10-05
Status : Inactive
Type : II
NDC Package Code : 65015-662
Start Marketing Date : 2015-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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