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

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01 Ami Lifesciences Private Limited (2)

02 Bidachem SpA (1)

03 Dongwha Pharmaceutical Co., Ltd. (1)

04 Hwail Pharmaceutical Co., Ltd. (2)

05 PEN TSAO CHEMICAL INDUSTRY LTD. (1)

06 Shilpa Medicare Limited (1)

07 Shilpa Pharma Lifesciences Limited (5)

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

02 Daesin Pharmaceutical Co., Ltd. (1)

03 Dongwha Pharmaceutical Co., Ltd. (1)

04 Hanmi Pharmaceutical Co., Ltd. (1)

05 Hiple Co., Ltd. (1)

06 Hwail Pharmaceutical Co., Ltd. (2)

07 IMCD Korea Co., Ltd. (2)

08 Kookjeon Pharmaceutical Co., Ltd. (1)

09 Opella Healthcare Korea Co., Ltd. (2)

10 Pharmapia Co., Ltd. (1)

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01 Ambroxol hydrochloride (13)

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01 China (1)

02 India (8)

03 Italy (1)

04 South Korea (3)

URL Supplier Web Content
Hanmi Pharmaceutical Co., Ltd.
2023-02-27
20221028-45-B-470-06(1)
Ami Lifesciences Private ...
India
Block No. 82/B, ECP Road ...
URL Supplier Web Content
Aging Life Science Co., Ltd.
2022-10-28
20221028-45-B-470-06
Ami Lifesciences Private ...
India
Block No. 82/B, ECP Road ...
URL Supplier Web Content
Opella Healthcare Korea Co., Ltd.
2005-08-31
20050831-45-B-117-04
Bidachem SpA
Italy
SS 11(Padana Superiore), ...
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Hwail Pharmaceutical Co., Ltd.
2014-10-20
20050831-45-B-116-03(1)
Hwail Pharmaceutical Co.,...
South Korea
57, Jaekongdan 3-gil, Hya...
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Opella Healthcare Korea Co., Ltd.
2020-04-01
20050915-45-B-206-05(7)
Shilpa Medicare Limited
India
1A & 1A'P', 1B, 2, 2A, 2B...
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Kookjeon Pharmaceutical Co., Ltd.
2020-03-25
20050915-45-B-206-05(6)
Shilpa Pharma Lifescience...
India
1A & 1A'P', 1B, 2, 2A, 2B...
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Pharmapia Co., Ltd.
2021-04-23
20050915-45-B-206-05(8)
Shilpa Pharma Lifescience...
India
1A & 1A'P', 1B, 2, 2A, 2B...
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IMCD Korea Co., Ltd.
2005-09-15
20050915-45-B-206-05
Shilpa Pharma Lifescience...
India
1A & 1A'P', 1B, 2, 2A, 2B...
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Hiple Co., Ltd.
2016-07-29
20050915-45-B-206-05(5)
Shilpa Pharma Lifescience...
India
1A & 1A'P', 1B, 2, 2A, 2B...
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Daesin Pharmaceutical Co., Ltd.
2011-08-05
20050915-45-B-206-05(2)
Shilpa Pharma Lifescience...
India
1A & 1A'P', 1B, 2, 2A, 2B...
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Looking for 1384955-66-1 / Ambroxol Hydrochloride API manufacturers, exporters & distributors?

Ambroxol Hydrochloride manufacturers, exporters & distributors 1

83

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

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

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

API | Excipient name

Ambroxol Hydrochloride

Synonyms

23828-92-4, Ambroxol hcl, Mucoangin, Mucosolvan, Ambroxolhydrochloride, 1384955-66-1

Cas Number

1384955-66-1

Unique Ingredient Identifier (UNII)

R3593UZ7HS

About Ambroxol Hydrochloride

A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.

Ambroxol HCl Manufacturers

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

Ambroxol HCl Suppliers

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

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

Ambroxol HCl KDMF

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

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

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

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

Ambroxol HCl Manufacturers | Traders | Suppliers

Ambroxol HCl Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Ambroxol HCl

Get in contact with the supplier of your choice:

  1. Ami Lifesciences Private Limited
  2. Bidachem
  3. DongWha Pharm
  4. Hwail Pharm Co., Ltd
  5. Pen Tsao Chemical
  6. Shilpa Medicare
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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