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

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01 Ami Lifesciences Pvt. Ltd. (2)

02 AMSA SpA (1)

03 AMSA SpA, (1)

04 Hanseochem Co., Ltd. (1)

05 Samhwa Biopharm Co., Ltd. (1)

06 Shilpa Medicare Limited (1)

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

02 Hanseochem Co., Ltd. (1)

03 Hyundai Pharmaceutical Co., Ltd. (1)

04 Jeil Pharmtech Co., Ltd. (1)

05 Pampia Co., Ltd. (1)

06 Samhwa Biopharm Co., Ltd. (1)

07 Sungjin Exim Co., Ltd. (1)

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01 Acebrophylline (3)

02 Acebrophylline (ambroxol acephyllate) (4)

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01 India (3)

02 Italy (2)

03 South Korea (2)

URL Supplier Web Content
Pampia Co., Ltd.
2021-06-26
20140313-152-I-341-08(1)
Ami Lifesciences Pvt. Ltd...
India
Block No. 82/B, ECP Road....
URL Supplier Web Content
Aging Life Science Co., Ltd.
2014-03-13
20140313-152-I-341-08
Ami Lifesciences Pvt. Ltd...
India
Block No. 82/B, ECP Road....
URL Supplier Web Content
Hyundai Pharmaceutical Co., Ltd.
2011-10-21
20110729-152-I-15-06(1)
AMSA SpA
Italy
Via G. Di Vittorio, 6 221...
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URL Supplier Web Content
Sungjin Exim Co., Ltd.
2011-07-29
20110729-152-I-15-06
AMSA SpA,
Italy
Via G. Di Vittorio, 6 221...
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Hanseochem Co., Ltd.
2012-10-17
20121017-152-I-206-02
Hanseochem Co., Ltd.
South Korea
41 Poseunggongdan-ro, Pos...
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Samhwa Biopharm Co., Ltd.
2012-11-28
20121128-152-I-237-03
Samhwa Biopharm Co., Ltd.
South Korea
150 Hyeopjeong-ro, Siheun...
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Jeil Pharmtech Co., Ltd.
2013-07-05
20130705-152-I-337-07
Shilpa Medicare Limited
India
Plot No. 33, 33A, 40 to 4...
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Looking for 96989-76-3 / Acebrophylline API manufacturers, exporters & distributors?

Acebrophylline manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Acebrophylline

Synonyms

Ambroxol acefyllinate, Ambromucil, Broncomnes, Surfolase, 96989-76-3, Ambroxol theophyllinacetate

Cas Number

96989-76-3

Unique Ingredient Identifier (UNII)

0HM1E174TN

Acebrophylline Manufacturers

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

Acebrophylline Suppliers

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

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

Acebrophylline KDMF

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

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

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

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

Acebrophylline Manufacturers | Traders | Suppliers

Acebrophylline Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Acebrophylline

Get in contact with the supplier of your choice:

  1. Ami Lifesciences Private Limited
  2. Amsa Spa
  3. Hanseo Chem
  4. Samhwa Biopharm
  5. 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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