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 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1HRV Global Life Sciences
05 1Granules India Limited
06 1Aurobindo Pharma Limited
07 1Chromo Laboratories
08 2Divis Laboratories
09 1Guangzhou Tosun Pharmaceutical
10 2Hetero Drugs
11 1MSN Laboratories
12 1SMS Pharmaceuticals
13 1Sionc Pharmaceuticals
14 1Sun-shine Chem
15 1Zhejiang Bamboo Pharmaceuticals
01 3China
02 13India
03 1U.S.A
01 7Active
02 1Inactive
03 9Blank
01 2Valid
02 15Blank
01 17Blank
01 1WC-0021n
02 1WC-0030
03 1WC-0040
04 1WC-0040A3
05 1WC-0273
06 12Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38089
Submission : 2023-06-14
Status : Active
Type : II
NDC Package Code : 42765-059
Start Marketing Date : 2023-06-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35430
Submission : 2020-12-29
Status : Active
Type : II
NDC Package Code : 62207-975
Start Marketing Date : 2021-04-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-05
Pay. Date : 2018-09-28
DMF Number : 33225
Submission : 2018-09-28
Status : Active
Type : II
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0106
Start Marketing Date : 2009-08-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-12
Pay. Date : 2014-05-06
DMF Number : 27240
Submission : 2013-06-29
Status : Active
Type : II
Certificate Number : R1-CEP 2015-344 - Rev 00
Issue Date : 2021-11-02
Type : Chemical
Substance Number : 2305
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0081
Start Marketing Date : 2013-06-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2023-11-15
Registration Number : 20231115-209-J-1564
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : Sy. No. 317 & 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pin code: 502 329, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-06
Pay. Date : 2018-09-27
DMF Number : 33154
Submission : 2018-09-22
Status : Active
Type : II
Certificate Number : R0-CEP 2019-099 - Rev 00
Issue Date : 2022-01-27
Type : Chemical
Substance Number : 2305
Status : Valid
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0033
Start Marketing Date : 2018-02-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-02-25
Valid Till : 2022-07-03
Written Confirmation Number : WC-0040A3
Address of the Firm :
NDC Package Code : 65977-0106
Start Marketing Date : 2009-08-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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