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List of Certificates of Suitability (CEPs) for Sertraline Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 Moehs Iberica S.L. Rubi ES (1)

02 AMOLI ORGANICS PRIVATE LIMITED Mumbai IN (1)

03 APITORIA PHARMA PRIVATE LIMITED Hyderabad IN (1)

04 AUROBINDO PHARMA LIMITED Hyderabad IN (1)

05 CIPLA LIMITED Mumbai IN (1)

06 DR. REDDY'S LABORATORIES LIMITED Hyderabad IN (2)

07 HETERO DRUGS LIMITED Hyderabad IN (4)

08 LUPIN LIMITED Mumbai IN (1)

09 MYLAN LABORATORIES LIMITED Hyderabad IN (2)

10 NATCO PHARMA LIMITED Hyderabad IN (1)

11 SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN (2)

12 Sandoz Syntek Ilaç Hammaddeleri Sanayi Ve Ticaret A.S. Istanbul TR (1)

13 TYCHE INDUSTRIES LIMITED Hyderabad IN (2)

14 VERDANT LIFE SCIENCES PVT., LIMITED Visakhapatnam IN (1)

15 Wanbury Limited Vashi, Navi Mumbai IN (2)

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01 Sertraline hydrochloride (12)

02 Sertraline hydrochloride, Alternate process (1)

03 Sertraline hydrochloride, Form I (2)

04 Sertraline hydrochloride, Form II (2)

05 Sertraline hydrochloride, Form-I (2)

06 Sertraline hydrochloride, Form-II, Process-II (1)

07 Sertraline hydrochloride, Process II (1)

08 Sertraline hydrochloride, Process IVB (1)

09 Sertraline hydrochloride, Process-II (1)

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01 Germany (1)

02 India (19)

03 Spain (1)

04 U.S.A (2)

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01 Expired (1)

02 Valid (17)

03 Withdrawn by Holder (5)

URL Supplier Web Content
CEP 2014-195 - Rev 02
Valid
Chemical
2023-09-20
1705
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R1-CEP 2012-218 - Rev 04
Valid
Chemical
2022-09-06
1705
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R1-CEP 2009-115 - Rev 02
Valid
Chemical
2016-09-13
1705
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R1-CEP 2017-264 - Rev 00
Valid
Chemical
2023-05-05
1705
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R1-CEP 2008-265 - Rev 01
Valid
Chemical
2020-05-27
1705
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R0-CEP 2022-313 - Rev 00
Valid
Chemical
2022-10-27
1705
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R0-CEP 2022-191 - Rev 00
Valid
Chemical
2023-08-31
1705
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R0-CEP 2023-151 - Rev 00
Valid
Chemical
2023-07-12
1705
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R1-CEP 2008-173 - Rev 06
Valid
Chemical
2022-04-08
1705
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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 CEP

A Sertraline CEP of the European Pharmacopoeia monograph is often referred to as a Sertraline Certificate of Suitability (COS). The purpose of a Sertraline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sertraline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sertraline to their clients by showing that a Sertraline CEP has been issued for it. The manufacturer submits a Sertraline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sertraline CEP holder for the record. Additionally, the data presented in the Sertraline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sertraline DMF.

A Sertraline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sertraline CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Sertraline suppliers with CEP (COS) 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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