Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
01 1Rochem International Inc
02 1Transo-Pharm USA LLC
03 1Nuray Chemicals Private Limited
04 1Sigmak Lifesciences
05 1SCI Pharmtech
06 1Aurobindo Pharma Limited
07 1Biocare Pharmaceutical
08 1Lupin Ltd
09 1Pfizer Inc
10 1Symed Labs
11 1Viatris
12 1Yaopharma
13 1Zhejiang Hisoar Pharmaceutical
14 1Zhejiang Tiantai Pharmaceutical
01 3China
02 5India
03 1Taiwan
04 1Turkey
05 4U.S.A
01 6Active
02 2Inactive
03 6Blank
01 14Blank
01 14Blank
01 1WC-0118
02 13Blank
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-30
Pay. Date : 2013-02-19
DMF Number : 24917
Submission : 2011-05-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-17
Pay. Date : 2013-09-16
DMF Number : 27276
Submission : 2013-09-22
Status : Active
Type : II
NDC Package Code : 67321-303
Start Marketing Date : 2015-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2015-01-26
DMF Number : 13412
Submission : 1998-09-01
Status : Active
Type : II
NDC Package Code : 0009-0063
Start Marketing Date : 2014-07-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-10
Pay. Date : 2013-09-16
DMF Number : 23974
Submission : 2010-07-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-21
Pay. Date : 2013-08-23
DMF Number : 26791
Submission : 2012-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24018
Submission : 2010-08-02
Status : Inactive
Type : II
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-759
Start Marketing Date : 2015-06-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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