Paracetamol Paracetamol

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List of Korea Drug Master Files (KDMF) for Acetaminophen Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Korea Johnson & Johnson Sales Co., Ltd.
2020-05-19
20200519-32-C-390-25
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Dongkwang Pharmaceutical Co., Ltd.
2018-11-09
20141022-32-C-325-19(9)
Anhui BBCA LiKang Pharmac...
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Pampia Co., Ltd.
2018-04-23
20141022-32-C-325-19(8)
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Toru Co., Ltd.
2017-06-28
20141022-32-C-325-19(7)
Anhui BBCA Likang Pharmac...
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NO.6288 Donghai Road, Hig...
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Narsha Farm Co., Ltd.
2022-09-16
20050831-32-C-129-08(29)
Anqiu Luan Pharmaceutical...
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No.35, Weixu North Road, ...
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GMAX Pharmachem Co., Ltd.
2017-04-24
20050831-32-C-129-08(24)
Anqiu Luan Pharmaceutical...
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No. 35, Weixu North Road,...
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Hiple Co., Ltd.
2018-06-14
20050831-32-C-129-08(25)
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Farm East Co., Ltd.
2020-03-25
20050831-32-C-129-08(28)
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Wonpoong Pharmaceutical Co., Ltd.
2019-04-23
20050831-32-C-129-08(26)
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Pharmapia Co., Ltd.
2020-03-03
20050831-32-C-129-08(27)
Anqiu Luan Pharmaceutical...
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NO. No. 35, Weixu North R...
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Hanareum Farm Co., Ltd.
2023-05-30
20050831-32-C-129-08(30)
Anqiu Luan Pharmaceutical...
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Ecell Bio Co., Ltd.
2016-02-25
20050831-32-C-129-08(23)
Anqiu Lu'an Pharmaceutica...
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No. 35, Weixu North Road,...
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Toru Co., Ltd.
2023-12-07
20050831-32-C-129-08(31)
Anqiu Luan Pharmaceutical...
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IMCD Korea Co., Ltd.
2016-01-22
20050831-32-C-129-08(22)
Anqiu Lu'an Pharmaceutica...
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No. 35, Weixu North Road,...
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Kyungbo Pharmaceutical Co., Ltd.
2021-03-26
20210326-32-C-382-26
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Eden Pharma Co., Ltd.
2020-01-21
20200121-32-C-386-24
Eden Pharma Co., Ltd.@Lia...
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1149@No.2 Nongdari-ro, Mu...
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Huons Co., Ltd.
2019-10-10
20151015-32-C-350-20(23)
Lianyungang Kangle Pharma...
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Hiple Co., Ltd.
2019-02-26
20180621-32-C-371-22(2)
Farmson Pharmaceutical Gu...
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Kosha Bio Co., Ltd.
2019-02-12
20180621-32-C-371-22(1)
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QI Trading Co., Ltd.
2018-06-21
20180621-32-C-371-22
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Inseong Trading Co., Ltd.
2023-03-29
20050915-32-C-198-10(B)
Granules India Ltd
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Korea Johnson & Johnson Sales Co., Ltd.
2023-03-03
20050915-32-C-198-10(A)
Granules India Ltd
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Happy Call Co., Ltd.
2016-11-24
20161124-32-C-355-21
Shenzhou Jiheng Pharmaceu...
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West of Guoxin Road, Xiji...
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Hanall Biopharma Co., Ltd.
2019-06-20
20161124-32-C-355-21(1)
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Happy Call Co., Ltd.
2019-01-11
20190111-32-C-375-23
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West of Guoxin Road, Xiji...
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Wonpoong Pharmaceutical Co., Ltd.
2022-11-07
20050831-32-C-120-03(1)
Sri Krishna Pharmaceutica...
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Unit-I, C-4, Industrial A...
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Korea Johnson & Johnson Sales Co., Ltd.
2023-01-10
20050831-32-C-126-07(A)
SpecGx LLC
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8801 Capital Boulevard, R...
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Leesung International Co., Ltd.
2020-07-01
20050831-32-C-126-07(4)
SpecGx LLC
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8801 Capital Boulevard, R...
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Agerson Bio Co., Ltd.
2022-06-10
20050831-32-C-126-07(5)
SpecGx LLC
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8801 Capital Boulevard, R...
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Toru Co., Ltd.
2023-01-04
20050831-32-C-120-03(2)
Sri Krishna Pharmaceutica...
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SG Biochem Co., Ltd.
2017-05-04
20151015-32-C-350-20(19)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Sama Pharmaceutical Co., Ltd.
2016-05-27
20151015-32-C-350-20(17)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Gan Yu...
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Hiple Co., Ltd.
2016-05-02
20151015-32-C-350-20(13)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Chong Kun Dang Co., Ltd.
2017-12-08
20151015-32-C-350-20(20)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Narsha Farm Co., Ltd.
2021-07-15
20151015-32-C-350-20(25)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Wonpoong Pharmaceutical Co., Ltd.
2017-11-17
20151015-32-C-350-20(21)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Dong-A Pharmaceutical Co., Ltd.
2016-03-16
20151015-32-C-350-20(12)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Farm & Biz Co., Ltd.
2016-02-25
20151015-32-C-350-20(11)
Lian Yun Gang Kangle Phar...
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No2,South China Road, Gan...
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Sungwoo Chemical Co., Ltd.
2016-02-25
20151015-32-C-350-20(10)
Lianyungang Kangle Pharma...
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Ilyang Pharmaceutical Co., Ltd.
2016-02-23
20151015-32-C-350-20(9)
Lianyungang Kangle Pharma...
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No.2, Huanan Road, Ganyu ...
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Toru Co., Ltd.
2016-02-16
20151015-32-C-350-20(6)
Lianyungang Kangle Pharma...
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Sanil Pharma Co., Ltd.
2016-02-16
20151015-32-C-350-20(8)
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Dongwha Pharmaceutical Co., Ltd.
2020-06-15
20151015-32-C-350-20(24)
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2016-01-22
20151015-32-C-350-20(5)
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2023-11-20
20151015-32-C-350-20(27)
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2023-11-20
20151015-32-C-350-20(28)
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Ace Biopharm Co., Ltd.
2019-07-24
20151015-32-C-350-20(22)
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2016-07-29
20151015-32-C-350-20(16)
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2022-05-03
20151015-32-C-350-20(26)
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2016-07-06
20151015-32-C-350-20(15)
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  • SUPPOSITORY;RECTAL - 120MG
  • SUPPOSITORY;RECTAL - 325MG
  • SUPPOSITORY;RECTAL - 650MG
  • SUPPOSITORY;RECTAL - 80MG
  • CAPSULE;ORAL - 325MG;50MG;40MG;30MG
  • TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 250MG;250MG;65MG
  • TABLET;ORAL - 325MG;37.5MG
  • SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML)
  • TABLET;ORAL - 300MG;15MG
  • TABLET;ORAL - 300MG;30MG
  • TABLET;ORAL - 300MG;60MG
  • TABLET;ORAL - 325MG;5MG
  • TABLET;ORAL - 325MG;50MG;40MG
  • TABLET;ORAL - 300MG;60MG

Looking for 103-90-2 / Paracetamol API manufacturers, exporters & distributors?

Paracetamol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Paracetamol

Synonyms

4-acetamidophenol, 103-90-2, Tylenol, N-(4-hydroxyphenyl)acetamide, Apap, Panadol

Cas Number

103-90-2

Unique Ingredient Identifier (UNII)

362O9ITL9D

About Paracetamol

Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Acetaminophen Manufacturers

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

Acetaminophen Suppliers

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

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

Acetaminophen KDMF

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

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

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

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

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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