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

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01 Apotex Pharmachem India Private Limited. (1)

02 Hanseochem Co., Ltd. (1)

03 Hwail Pharmaceutical Co., Ltd. (2)

04 Kyungdong Pharmaceutical Co., Ltd. (1)

05 Maithri Drugs Private Limited (1)

06 Pfizer Ireland Pharmaceuticals (1)

07 Pfizer Pharmaceutical LLC (1)

08 Upjohn Manufacturing Ireland Unlimited Company (1)

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

02 Hanseochem Co., Ltd. (1)

03 Hwail Pharmaceutical Co., Ltd. (2)

04 Kyungdong Pharmaceutical Co., Ltd. (1)

05 Pfizer Pharmaceuticals Korea Co., Ltd. (3)

06 Samo Pharmaceutical Co., Ltd. (1)

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01 Varenicline (1)

02 Varenicline Tartrate (3)

03 Varenicline besylate monohydrate (1)

04 Varenicline fumarate (1)

05 Varenicline salicylate (1)

06 Varenicline tartaric acid (2)

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01 Canada (1)

02 India (1)

03 South Korea (4)

04 U.S.A (3)

URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2017-09-25
Wed207-35-ND
Apotex Pharmachem India P...
India
Plot No. 1A, Bommasandra ...
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Hanseochem Co., Ltd.
2018-03-21
2295-10-ND
Hanseochem Co., Ltd.
South Korea
41 Poseunggongdan-ro, Pos...
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Hwail Pharmaceutical Co., Ltd.
2017-12-04
2014-13-ND
Hwail Pharmaceutical Co.,...
South Korea
57, Jaekongdan 3-gil, Hya...
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Hwail Pharmaceutical Co., Ltd.
2018-10-10
2014-17-ND
Hwail Pharmaceutical Co.,...
South Korea
57, Jaekongdan 3-gil, Hya...
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Kyungdong Pharmaceutical Co., Ltd.
2018-09-10
1574-3-ND
Kyungdong Pharmaceutical ...
South Korea
15 Balangongdan-ro 2-gil,...
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Aging Life Science Co., Ltd.
2020-09-17
Number 434-21-ND
Maithri Drugs Private Lim...
India
Sy. No. 205, 222 to 226, ...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2014-10-22
Wed2582-19-ND
Pfizer Pharmaceutical LLC
Puerto Rico
PO Box 628 Road No.2 Km 5...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2007-03-28
Number 189-4-ND
Upjohn Manufacturing Irel...
Ireland
Little Island, Co, Cork, ...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2018-08-24
Wed87-24-ND
Pfizer Ireland Pharmaceut...
Ireland
Ringaskiddy API Plant, PO...
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Looking for 375815-87-5 / Varenicline API manufacturers, exporters & distributors?

Varenicline manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Varenicline

Synonyms

Varenicline tartrate, 375815-87-5, (2s,3s)-2,3-dihydroxybutanedioic acid; 5,8,14-triazatetracyclo[10.3.1.0^{2,11}.0^{4,9}]hexadeca-2(11),3,5,7,9-pentaene, (2s,3s)-2,3-dihydroxybutanedioic acid;5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene, Akos026750167, As-35136

Cas Number

375815-87-5

About Varenicline

A benzazepine derivative that functions as an ALPHA4-BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.

Varenicline Manufacturers

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

Varenicline Suppliers

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

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

Varenicline KDMF

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

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

After submitting a Varenicline 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 Varenicline API can apply through the Korea Drug Master File (KDMF).

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

Varenicline Manufacturers | Traders | Suppliers

Varenicline Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Varenicline

Get in contact with the supplier of your choice:

  1. Apotex Pharmachem
  2. Hanseo Chem
  3. Hwail Pharm Co., Ltd
  4. KyungDong Pharm
  5. Maithili Life Sciences
  6. Pfizer Inc
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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