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

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01 Glaxo Wellcome Manufacturing Pte Ltd (1)

02 Laurus Labs Limited (Unit 1) (1)

03 M/S. Aurobindo Pharma Limited, Unit-XI (1)

04 Mylan Laboratories Limited (Unit 2) (1)

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01 GlaxoSmithKline Co., Ltd. (2)

02 MSD Korea Co., Ltd. (1)

03 Seongui Bio Co., Ltd. (1)

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01 Lamivudine (4)

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01 India (2)

02 U.S.A (1)

03 United Kingdom (1)

URL Supplier Web Content
Seongui Bio Co., Ltd.
2021-03-23
20210323-209-J-757
M/S. Aurobindo Pharma Lim...
India
Survey Nos. 1/22,2/1 to 5...
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GSK

Contact Supplier
  • FDA
  • EDQM
  • WHO-GMP
URL Supplier Web Content
GlaxoSmithKline Co., Ltd.
2021-03-16
20210316-209-J-876
Glaxo Wellcome Manufactur...
Singapore
1 pioneer Sector 1, Juron...
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URL Supplier Web Content
MSD Korea Co., Ltd.
2022-01-10
20220110-209-J-1202
Laurus Labs Limited (Unit...
India
Plot No.21, Jawaharlal Ne...
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URL Supplier Web Content
GlaxoSmithKline Co., Ltd.
2020-03-05
20200305-209-J-420
Mylan Laboratories Limite...
India
Survey No. 10 & 42, Gadda...
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Looking for 134678-17-4 / Lamivudine API manufacturers, exporters & distributors?

Lamivudine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lamivudine

Synonyms

134678-17-4, Epivir, Zeffix, Heptovir, Epivir-hbv, 136891-12-8

Cas Number

134678-17-4

Unique Ingredient Identifier (UNII)

2T8Q726O95

About Lamivudine

A reverse transcriptase inhibitor and ZALCITABINE analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat HIV disease.

Lamivudine Manufacturers

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

Lamivudine Suppliers

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

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

Lamivudine KDMF

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

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

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

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

Lamivudine Manufacturers | Traders | Suppliers

Lamivudine Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Lamivudine

Get in contact with the supplier of your choice:

  1. Aurobindo Pharma Limited
  2. GSK
  3. Laurus Labs
  4. Viatris
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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