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

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01 Cadila Healthcare Limited (1)

02 Cadila Limited (1)

03 Cadila Pharmaceutical Limited. (1)

04 Cadila Pharmaceuticals Limited (4)

05 Cadila Pharmaceuticals Limited. (5)

06 Cadila Pharmaceuticals Ltd. (1)

07 MSD International GmbH (Singapore Branch) (1)

08 Mylan Laboratories Limited (2)

09 Schering-Plough (Avondale) Co (1)

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

02 Bayer Korea Co., Ltd. (1)

03 Bijeon Pharmaceutical Co., Ltd. (1)

04 Daesin Pharmaceutical Co., Ltd. (1)

05 Goodwills Co., Ltd. (1)

06 Hanall Biopharma Co., Ltd. (1)

07 Hiple Co., Ltd. (1)

08 Hwail Pharmaceutical Co., Ltd. (1)

09 IMCD Korea Co., Ltd. (1)

10 Kookjeon Pharmaceutical Co., Ltd. (1)

11 Korea United Pharmaceutical Co., Ltd. (1)

12 MSD Korea Co., Ltd. (2)

13 Pharmapia Co., Ltd. (1)

14 Sangjin Trading Co., Ltd. (1)

15 Sanil Pharma Co., Ltd. (1)

16 Sungwoo Chemical Co., Ltd. (1)

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01 Loratadine (17)

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01 India (13)

02 U.S.A (4)

URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2012-05-04
20120504-6-C-286-07
Mylan Laboratories Limite...
India
Plot No. 14,99 & 100, IDA...
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Bayer Korea Co., Ltd.
2022-11-14
20120504-6-C-286-07(1)
Mylan Laboratories Limite...
India
Plot No. 14,99 & 100, IDA...
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Daesin Pharmaceutical Co., Ltd.
2011-07-15
20050831-6-C-68-03(3)
Cadila Pharmaceuticals Li...
India
294, GIDC, Ankleshwar, Gu...
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Korea United Pharmaceutical Co., Ltd.
2011-11-25
20050831-6-C-68-03(6)
Cadila Pharmaceuticals Li...
India
294, GIDC, Ankleshwar, Gu...
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Pharmapia Co., Ltd.
2017-02-14
20050831-6-C-68-03(10)
Cadila Pharmaceuticals Lt...
India
294, GIDC, Ankleshwar, Gu...
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Hanall Biopharma Co., Ltd.
2012-10-25
20050831-6-C-68-03(8)
Cadila Pharmaceuticals Li...
India
294, GIDC, Ankleshwar, Gu...
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Aging Life Science Co., Ltd.
2020-02-12
20050831-6-C-68-03(11)
Cadila Pharmaceuticals Li...
India
294, GIDC, Ankleshwar, Gu...
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Hwail Pharmaceutical Co., Ltd.
2012-03-23
20050831-6-C-68-03(7)
Cadila Limited
India
294, GIDC, Ankleshwar, Gu...
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Sanil Pharma Co., Ltd.
2020-04-21
20050831-6-C-68-03(12)
Cadila Pharmaceuticals Li...
India
294, GIDC, Ankleshwar, Gu...
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Hiple Co., Ltd.
2011-08-05
20050831-6-C-68-03(5)
Cadila Pharmaceuticals Li...
India
294, GIDC, Ankleshwar, Gu...
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Looking for 79794-75-5 / Loratadine API manufacturers, exporters & distributors?

Loratadine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Loratadine

Synonyms

79794-75-5, Claritin, Alavert, Loratidine, Clarityn, Lisino

Cas Number

79794-75-5

Unique Ingredient Identifier (UNII)

7AJO3BO7QN

About Loratadine

A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.

Loratadine Manufacturers

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

Loratadine Suppliers

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

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

Loratadine KDMF

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

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

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

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

Loratadine Manufacturers | Traders | Suppliers

Loratadine Manufacturers, Traders, Suppliers 1
51

We have 4 companies offering Loratadine

Get in contact with the supplier of your choice:

  1. Cadila Pharmaceuticals
  2. Merck & Co
  3. Viatris
  4. Zydus Lifesciences
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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