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List of Drug Master Files (DMF) of Duloxetine Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dr. Reddy's Laboratories (1)

02 Moehs Iberica (1)

03 Ajanta Pharma Limited (1)

04 Alembic Pharmaceuticals Limited (2)

05 Alkem Laboratories (1)

06 Aurobindo Pharma Limited (2)

07 CTX Lifesciences (1)

08 Cadila Pharmaceuticals (1)

09 Chongqing Shenghuaxi Pharma. Co., Ltd (1)

10 Erregierre SpA (1)

11 Esteve Quimica (1)

12 HEC Pharm (1)

13 Hansoh Pharma (1)

14 Hetero Drugs (1)

15 Jubilant Generics (1)

16 Lupin Ltd (2)

17 MATRIX LABORATORIES XIAMEN LTD. (1)

18 MSN Laboratories (2)

19 Macleods Pharmaceuticals Limited (2)

20 Nosch Labs Pvt. Ltd. (1)

21 Olon S.p.A (1)

22 Orchid Pharma (1)

23 R L Fine Chem (1)

24 RANBAXY LABORATORIES LIMITED (1)

25 SCI PHARMTECH (2)

26 Shanghai Wonder Pharmaceutical (1)

27 Shodhana Laboratories Pvt. Ltd (1)

28 Signa S.A. de C.V. (1)

29 Sun Pharmaceutical Industries Limited (1)

30 Teva API (1)

31 Torrent Pharmaceuticals Limited (1)

32 Viatris (1)

33 Wockhardt (1)

34 Zhejiang Huahai Pharmaceutical (1)

35 Zhejiang Jiuzhou Pharmaceutical (1)

36 Zhejiang Liaoyuan Pharmaceutical Co LTD (1)

37 Zhejiang Yongtai Technology (1)

38 Zydus Lifesciences (3)

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01 DULOXETINE HCL (1)

02 DULOXETINE HCL DRUG SUBSTANCE (1)

03 DULOXETINE HYDROCHLORIDE (15)

04 DULOXETINE HYDROCHLORIDE (FROM (S)-MMAA-OME) (1)

05 DULOXETINE HYDROCHLORIDE (NON-STERILE BULK API) (1)

06 DULOXETINE HYDROCHLORIDE DELAYED-RELEASE PELLETS (1)

07 DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE (1)

08 DULOXETINE HYDROCHLORIDE EP-USP (1)

09 DULOXETINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (1)

10 DULOXETINE HYDROCHLORIDE USP (12)

11 DULOXETINE HYDROCHLORIDE USP (DUB ROUTE) (1)

12 DULOXETINE HYDROCHLORIDE USP (DUX PROCES) (1)

13 DULOXETINE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (1)

14 DULOXETINE HYDROCHLORIDE USP (PROCESS B) (1)

15 DULOXETINE HYDROCHLORIDE USP (PROCESS II) (1)

16 DULOXETINE HYDROCHLORIDE USP (PROCESS-II) (1)

17 DULOXETINE HYDROCHLORIDE USP [ROUTE CODE - DX"] (1)

18 DULOXETINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

19 DULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE (1)

20 DULOXETINE HYDROCHLORIDE, USP (2)

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01 China (9)

02 India (28)

03 Israel (1)

04 Italy (2)

05 Mexico (1)

06 Spain (2)

07 Taiwan (2)

08 U.S.A (1)

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01 Active (32)

02 Inactive (14)

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01 Complete (16)

02 Blank (30)

URL Supplier Web Content
21767
Active
2008-06-27
N/A
II
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21524
Active
2008-04-08
N/A
II
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20996
Active
2007-10-30
Complete
2020-11-17
2020-11-10
II
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21635
Active
2008-06-27
N/A
II
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21752
Active
2008-07-21
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21485
Active
2008-03-31
N/A
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21478
Active
2008-03-29
Complete
2018-02-23
2018-02-09
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21604
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2008-04-29
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Looking for 136434-34-9 / Duloxetine API manufacturers, exporters & distributors?

Duloxetine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Duloxetine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Duloxetine manufacturer or Duloxetine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Duloxetine manufacturer or Duloxetine supplier.

PharmaCompass also assists you with knowing the Duloxetine API Price utilized in the formulation of products. Duloxetine API Price is not always fixed or binding as the Duloxetine Price is obtained through a variety of data sources. The Duloxetine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Duloxetine

Synonyms

136434-34-9, Duloxetine hcl, Cymbalta, (s)-duloxetine hydrochloride, Ariclaim, Xeristar

Cas Number

136434-34-9

Unique Ingredient Identifier (UNII)

9044SC542W

About Duloxetine

A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.

Duloxetine Hydrochloride Manufacturers

A Duloxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duloxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Duloxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duloxetine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Duloxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Duloxetine Hydrochloride Suppliers

A Duloxetine Hydrochloride supplier is an individual or a company that provides Duloxetine Hydrochloride active pharmaceutical ingredient (API) or Duloxetine Hydrochloride finished formulations upon request. The Duloxetine Hydrochloride suppliers may include Duloxetine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Duloxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Duloxetine Hydrochloride USDMF

A Duloxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Duloxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Duloxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Duloxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Duloxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Duloxetine Hydrochloride USDMF includes data on Duloxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duloxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Duloxetine Hydrochloride suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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