Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 1Metrochem API Private Limited
02 2Dr. Reddy's Laboratories
03 1Granules India Limited
04 2AstraZeneca
05 1Aurobindo Pharma Limited
06 1CHEMO
07 1Chromo Laboratories
08 1Cipla
09 1Credo Life Sciences
10 2Dishman Carbogen Amcis
11 1ENAL DRUGS
12 1Everest Organics
13 1Hetero Drugs
14 1Lee Pharma
15 1Lupin Ltd
16 1Merck & Co
17 2Nosch Labs Pvt
18 1RANBAXY LABORATORIES LIMITED
19 1Raks Pharma
20 1SINTENOVO, S.A. DE C.V.
21 1Sandoz B2B
22 1Shouguang Fukang Pharmaceutical Co., Ltd
23 1Sun Pharmaceutical Industries Limited
24 1UQUIFA
25 1Viatris
01 1China
02 20India
03 1Mexico
04 2Spain
05 1Switzerland
06 2U.S.A
07 2United Kingdom
01 11Active
02 4Inactive
03 14Blank
01 8Valid
02 2Withdrawn by Holder
03 19Blank
01 29Blank
01 1WC-0011nA2
02 1WC-0023
03 1WC-0024
04 1WC-0027
05 1WC-0035a
06 1WC-0040
07 1WC-0043Amended
08 1WC-0113
09 1WC-0135
10 1WC-0135A
11 1WC-0384
12 1WC-0493
13 17Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-24
Pay. Date : 2024-05-23
DMF Number : 35390
Submission : 2020-11-20
Status : Active
Type : II
Certificate Number : CEP 2020-380 - Rev 02
Issue Date : 2024-06-20
Type : Chemical
Substance Number : 2374
Status : Valid
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-017
Start Marketing Date : 2020-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17706
Submission : 2004-09-24
Status : Active
Type : II
Certificate Number : R0-CEP 2022-115 - Rev 00
Issue Date : 2023-08-17
Type : Chemical
Substance Number : 2374
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-049
Start Marketing Date : 2004-09-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-12
Pay. Date : 2021-09-29
DMF Number : 31829
Submission : 2017-08-31
Status : Active
Type : II
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-006
Start Marketing Date : 2018-07-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38882
Submission : 2023-09-29
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043Amended
Address of the Firm :
NDC Package Code : 55111-049
Start Marketing Date : 2004-09-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-07
Pay. Date : 2015-09-23
DMF Number : 27734
Submission : 2013-11-13
Status : Active
Type : II
Certificate Number : R1-CEP 2015-341 - Rev 00
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 2374
Status : Valid
NDC Package Code : 64374-009
Start Marketing Date : 2016-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-17
Pay. Date : 2013-08-29
DMF Number : 27190
Submission : 2013-09-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-23
Pay. Date : 2016-09-30
DMF Number : 30335
Submission : 2016-11-23
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-02
Written Confirmation Number : WC-0011nA2
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21100
Submission : 2007-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19367
Submission : 2006-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14649
Submission : 1999-12-30
Status : Inactive
Type : II
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