TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
01 1Transo-Pharm USA LLC
02 1Nuray Chemicals Private Limited
03 1Rochem International Inc
04 1Aurobindo Pharma Limited
05 1Biocare Pharmaceutical
06 1Lupin Ltd
07 1Pfizer Inc
08 1Symed Labs
09 1Viatris
10 1Yaopharma
11 1Zhejiang Hisoar Pharmaceutical
12 1Zhejiang Tiantai Pharmaceutical
01 3China
02 4India
03 1Turkey
04 4U.S.A
01 5Active
02 2Inactive
03 5Blank
01 12Blank
01 12Blank
01 1WC-0118
02 11Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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 : 2025-12-31
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 : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23436
Submission : 2009-12-31
Status : Active
Type : II
NDC Package Code : 65862-545
Start Marketing Date : 2023-11-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23115
Submission : 2009-09-30
Status : Inactive
Type : II
NDC Package Code : 39635-0004
Start Marketing Date : 2022-05-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Clindamycin Palmitate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clindamycin Palmitate, including repackagers and relabelers. The FDA regulates Clindamycin Palmitate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clindamycin Palmitate 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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