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List of Drug Master Files (KDMF) for Sertraline Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Asia Chemical Industries Ltd. Teva-Tech Site (1)

02 Aurobindo Pharma ltd. (4)

03 Hanmi Fine Chemical Co., Ltd. (1)

04 Hetero Drugs Limited Unit I (1)

05 Pfizer Asia Manufacturing Pte Ltd (1)

06 Pfizer Ireland Pharmaceuticals Ringaskiddy Drug Substance Plant (1)

07 Pfizer Pharmaceuticals LLC (1)

08 Recordati Industria Chimica & Farmaceutica SpA (1)

09 Recordati Industria Chimica E Farmaceutica SpA (1)

10 Sandoz Syntek ilac Hammaddeleri Sanayi ve Ticaret AS (1)

11 Teva API India Pvt. Ltd (1)

12 Zhejiang LEPU Pharmaceutical Co., Ltd. (1)

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01 Aging Life Science Co., Ltd. (1)

02 Base Farm Co., Ltd. (1)

03 Beatrice Korea Co., Ltd. (3)

04 Hanmi Fine Chemical Co., Ltd. (1)

05 Kookjeon Pharmaceutical Co., Ltd. (2)

06 Leesung International Co., Ltd. (1)

07 Myungin Pharmaceutical Co., Ltd. (1)

08 Samo Pharmaceutical Co., Ltd. (2)

09 Sandoz Korea Co., Ltd. (1)

10 Seongui Bio Co., Ltd. (1)

11 Seongyi Pharmaceutical Co., Ltd. (1)

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01 Sertraline hydrochloride (15)

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01 China (1)

02 India (5)

03 Israel (2)

04 Slovakia (1)

05 South Korea (1)

06 U.S.A (5)

URL Supplier Web Content
Base Farm Co., Ltd.
2021-04-16
20050915-39-C-197-06(3)
Aurobindo Pharma ltd.
India
Unit-VIII, Sy. no. 10 & 1...
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Seongyi Pharmaceutical Co., Ltd.
2013-01-28
20050915-39-C-197-06(1)
Aurobindo Pharma ltd.
India
Sy.No.13, Gaddapotharam(V...
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Aging Life Science Co., Ltd.
2019-01-21
20050915-39-C-197-06(2)
Aurobindo Pharma ltd.
India
Sy. No.10 & 13, Gaddapoth...
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Leesung International Co., Ltd.
2023-05-19
20230519-39-C-403-13
Hetero Drugs Limited Unit...
India
Survey. No's 213, 214 and...
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Beatrice Korea Co., Ltd.
2020-09-15
20200915-39-C-391-12
Pfizer Asia Manufacturing...
Singapore
31 Tuas South Avenue 6 Si...
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Beatrice Korea Co., Ltd.
2007-12-28
20071228-39-C-235-09
Pfizer Pharmaceuticals LL...
Puerto Rico
KM58.2 Road #2, Barcelone...
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Myungin Pharmaceutical Co., Ltd.
2007-05-04
20070504-39-C-227-08
Recordati Industria Chimi...
Italy
Via Mediana Cisterna, 4-0...
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Kookjeon Pharmaceutical Co., Ltd.
2014-05-09
20070504-39-C-227-08(1)
Recordati Industria Chimi...
Italy
Via Mediana Cisterna, 4-0...
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Samo Pharmaceutical Co., Ltd.
2013-06-18
20130618-39-C-316-11
Teva API India Pvt. Ltd
India
Plot No. A-2, A-2/1, A-2/...
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Kookjeon Pharmaceutical Co., Ltd.
2024-01-08
20240108-39-C-407-14
Zhejiang LEPU Pharmaceuti...
China
8@No.29 , Balangongdan-ro...
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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 Hydrochloride Manufacturers

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

Sertraline Hydrochloride Suppliers

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

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

Sertraline Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Sertraline Hydrochloride Drug Master File in Korea (Sertraline Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sertraline Hydrochloride. The MFDS reviews the Sertraline Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Sertraline Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Sertraline Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sertraline Hydrochloride API can apply through the Korea Drug Master File (KDMF).

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

Sertraline Hydrochloride Manufacturers | Traders | Suppliers

Sertraline Hydrochloride 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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