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List of Drug Master Files (DMF) of Sertraline 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 ALP Pharm (1)

03 Amoli Organics (1)

04 Aurobindo Pharma Limited (2)

05 Chemeca Drugs (1)

06 Cipla (3)

07 Hetero Drugs (3)

08 Lee Pharma (1)

09 Lupin Ltd (1)

10 PHF SA (1)

11 RANBAXY LABORATORIES LIMITED (1)

12 Recordati (1)

13 Sun Pharmaceutical Industries Limited (1)

14 Symed Labs (1)

15 Teva API (1)

16 Torrent Pharmaceuticals Limited (1)

17 Viatris (1)

18 Wanbury Limited (2)

19 Zydus Lifesciences (1)

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01 SERTRALINE HCL USP (FORM II PROCESS I) (1)

02 SERTRALINE HYDROCHLORIDE (5)

03 SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) (1)

04 SERTRALINE HYDROCHLORIDE (FORM II) (2)

05 SERTRALINE HYDROCHLORIDE (FORM-I) (1)

06 SERTRALINE HYDROCHLORIDE (FORM-I) USP (1)

07 SERTRALINE HYDROCHLORIDE DRUG SUBSTANCE (1)

08 SERTRALINE HYDROCHLORIDE DRUG SUBTANCE (1)

09 SERTRALINE HYDROCHLORIDE FORM I (1)

10 SERTRALINE HYDROCHLORIDE FORM II (1)

11 SERTRALINE HYDROCHLORIDE FORM-II (1)

12 SERTRALINE HYDROCHLORIDE USP (3)

13 SERTRALINE HYDROCHLORIDE USP (CRYSTALLINE POLYMORPH FORM II) (1)

14 SERTRALINE HYDROCHLORIDE USP (FORM II) (1)

15 SERTRALINE HYDROCHLORIDE USP (FORM-V) (1)

16 SERTRALINE HYDROCHLORIDE USP CRYSTALLINE POLYMORPH FORM I (1)

17 SERTRALINE HYDROCHLORIDE, USP (FORM 1) (1)

18 SERTRALINE HYDROCHLORIDE, USP (FORM II), PROCESS II (1)

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01 China (1)

02 India (20)

03 Israel (1)

04 Italy (1)

05 Switzerland (1)

06 U.S.A (1)

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01 Active (14)

02 Inactive (11)

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01 Complete (6)

02 Blank (19)

URL Supplier Web Content
22652
Active
2009-03-21
Complete
2013-09-21
2013-09-13
II
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URL Supplier Web Content
17435
Active
2004-05-31
N/A
II
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25426
Active
2011-10-27
N/A
II
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25238
Active
2011-08-25
Complete
2013-07-23
2013-01-07
II
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18239
Active
2005-03-29
N/A
II
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URL Supplier Web Content
18311
Active
2005-04-29
N/A
II
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17325
Active
2004-04-20
N/A
II
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URL Supplier Web Content
19931
Active
2006-10-10
N/A
II
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URL Supplier Web Content
19035
Active
2005-12-13
Complete
2020-07-20
2020-07-08
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Looking for 79559-97-0 / Sertraline Hydrochloride API manufacturers, exporters & distributors?

Sertraline Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Sertraline Hydrochloride 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 Sertraline Hydrochloride manufacturer or Sertraline Hydrochloride supplier for your needs.

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

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

API | Excipient name

Sertraline Hydrochloride

Synonyms

79559-97-0, Sertraline hcl, Zoloft, Gladem, Lustral, Serad

Cas Number

79559-97-0

Unique Ingredient Identifier (UNII)

UTI8907Y6X

About Sertraline Hydrochloride

A selective serotonin uptake inhibitor that is used in the treatment of depression.

Sertraline Manufacturers

A Sertraline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sertraline, including repackagers and relabelers. The FDA regulates Sertraline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sertraline 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 Sertraline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sertraline Suppliers

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

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

Sertraline USDMF

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

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

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

Sertraline Manufacturers | Traders | Suppliers

Sertraline Manufacturers, Traders, Suppliers 1
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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