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

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01 Dr. Reddy's Laboratories Limited (1)

02 Dr. Reddy's Laboratories Limited._x000D_ (1)

03 Dr. Reddy's Laboratories Ltd (1)

04 Dr.Reddy's Laboratories, Ltd.@[Small powder manufacturing company] Hwail Pharmaceutical Co., Ltd. (1)

05 Supriya Lifescience Ltd (6)

06 Supriya Lifescience Ltd. (1)

07 COSMA SPA (1)

08 Cipla Limited (4)

09 Cipla Ltd. (1)

10 Glochem Industries Private Limited (1)

11 Glochem Industries Pvt. Ltd. (2)

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

13 IPCA Laboratories Limited (4)

14 Kyungdong Pharmaceutical Co., Ltd. (1)

15 Samo Pharmaceutical Co., Ltd. (1)

16 UCB Farchim S.A. (1)

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01 Daesin Pharmaceutical Co., Ltd. (2)

02 Dongkwang Pharmaceutical Co., Ltd. (1)

03 Farm & Biz Co., Ltd. (1)

04 Farmirae Co., Ltd. (1)

05 GL Pharma Co., Ltd. (1)

06 HK Innoen Co., Ltd. (1)

07 Hanall Biopharma Co., Ltd. (1)

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

09 Hwail Pharmaceutical Co., Ltd. (2)

10 IMCD Korea Co., Ltd. (2)

11 Kookjeon Pharmaceutical Co., Ltd. (1)

12 Korea UCB Pharmaceutical Co., Ltd. (1)

13 Kyungdong Pharmaceutical Co., Ltd. (1)

14 Samil Pharmaceutical Co., Ltd. (1)

15 Samo Pharmaceutical Co., Ltd. (2)

16 Sangjin Trading Co., Ltd. (1)

17 Sanil Pharma Co., Ltd. (1)

18 Sanil Pharmaceutical Co., Ltd. (1)

19 Shinpoong Pharmaceutical Co., Ltd. (1)

20 Sungjin Exim Co., Ltd. (2)

21 Sungwoo Chemical Co., Ltd. (1)

22 Unimed Pharmaceutical Co., Ltd. (1)

23 Wonpoong Pharmaceutical Co., Ltd. (1)

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01 Cetirizine hydrochloride (28)

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01 India (23)

02 Italy (1)

03 South Korea (2)

04 Switzerland (1)

05 Uzbekistan (1)

Farmirae Co., Ltd.
2022-09-16
20050831-40-C-145-06(4)
Dr. Reddy's Laboratories ...
India
Plot No. 137 & 138, 145 &...
Daesin Pharmaceutical Co., Ltd.
2021-11-08
20050831-40-C-139-01(7)
Supriya Lifescience Ltd.
India
A-5/2, Lote Parshuram Ind...
Sangjin Trading Co., Ltd.
2008-06-27
20080627-40-C-243-10
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
Hwail Pharmaceutical Co., Ltd.
2011-05-31
20050831-40-C-145-06(1)
Dr.Reddy's Laboratories, ...
India
Plot No. 137 & 138, 145 &...
Hwail Pharmaceutical Co., Ltd.
2005-08-31
20050831-40-C-145-06
Dr. Reddy's Laboratories ...
India
Plot No. 137 & 138, 145 &...
Kookjeon Pharmaceutical Co., Ltd.
2014-03-14
20050831-40-C-139-01(2)
Supriya Lifescience Ltd
India
A-5/2, Lote Parshuram Ind...
Sanil Pharma Co., Ltd.
2017-12-08
20050831-40-C-139-01(5)
Supriya Lifescience Ltd
India
A-5/2, Lote Parshuram Ind...
GL Pharma Co., Ltd.
2017-02-15
20050831-40-C-139-01(4)
Supriya Lifescience Ltd
India
A-5/2, Lote Parshuram Ind...
IMCD Korea Co., Ltd.
2014-06-05
20050831-40-C-139-01(3)
Supriya Lifescience Ltd
India
A-5/2, Lote Parshuram Ind...
Sanil Pharmaceutical Co., Ltd.
2019-06-11
20050831-40-C-139-01(6)
Supriya Lifescience Ltd
India
A-5/2, Lote Parshuram Ind...

Looking for 83881-52-1 / Cetirizine Dihydrochloride API manufacturers, exporters & distributors?

Cetirizine Dihydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cetirizine Dihydrochloride

Synonyms

83881-52-1, Zyrtec, Reactine, Cetirizine dihcl, Cetrine, 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride

Cas Number

83881-52-1

Unique Ingredient Identifier (UNII)

64O047KTOA

About Cetirizine Dihydrochloride

A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.

Cetirizine Dihydrochloride Manufacturers

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

Cetirizine Dihydrochloride Suppliers

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

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

Cetirizine Dihydrochloride KDMF

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

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

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

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

Cetirizine Dihydrochloride Manufacturers | Traders | Suppliers

Cetirizine Dihydrochloride Manufacturers, Traders, Suppliers 1
17

We have 10 companies offering Cetirizine Dihydrochloride

Get in contact with the supplier of your choice:

  1. Dr. Reddy's Laboratories
  2. Supriya Lifescience
  3. Cipla
  4. COSMA S.p.A
  5. Glochem Industries
  6. Hanmi Pharmaceutical
  7. Ipca Laboratories
  8. KyungDong Pharm
  9. SamoFarm
  10. UCB Farchim SA
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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