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

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01 Macfarlan Smith Limited@Macfarlan Smith Limited (2)

02 Harman Finochem Limited (1)

03 IPCA Laboratories Limited (1)

04 Janssen Pharmaceuticals, Inc. (1)

05 SCI Pharmtech, Inc. (1)

06 SpecGx LLC (2)

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

02 Alvogen Korea Co., Ltd. (2)

03 Hwanin Pharmaceutical Co., Ltd. (1)

04 Korea Janssen Co., Ltd. (1)

05 Korea Pharma Co., Ltd. (1)

06 Myungin Pharmaceutical Co., Ltd. (2)

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01 Methylphenidate hydrochloride (8)

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01 India (2)

02 Ireland (2)

03 Taiwan (1)

04 U.S.A (3)

Hwanin Pharmaceutical Co., Ltd.
2021-12-17
20210427-209-J-837(1)
Macfarlan Smith Limited@M...
U.S.A
10 Wheatfield Road, Edinb...
Myungin Pharmaceutical Co., Ltd.
2021-04-27
20210427-209-J-837
Macfarlan Smith Limited@M...
U.S.A
Three Trees Road Newbie, ...
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Alvogen Korea Co., Ltd.
2023-07-31
20230731-209-J-1530
Harman Finochem Limited
India
Plot No. E-7, E-8, E-9, M...
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Myungin Pharmaceutical Co., Ltd.
2021-04-16
20210416-209-J-940
IPCA Laboratories Limited
India
PO Sejavta Dist. Ratlam (...
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Korea Janssen Co., Ltd.
2020-07-15
20200715-209-J-691
Janssen Pharmaceuticals, ...
U.S.A
1440 Olympic Drive, Athen...
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Korea Pharma Co., Ltd.
2023-10-26
20231012-209-J-1551(A)
SpecGx LLC
U.S.A
3600 North Second Street,...
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Alvogen Korea Co., Ltd.
2023-10-12
20231012-209-J-1551
SpecGx LLC
U.S.A
3600 North Second Street,...
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Aging Life Science Co., Ltd.
2018-09-07
20180907-209-J-55
SCI Pharmtech, Inc.
Taiwan
No.61, Ln.309, Haihu N. R...
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Looking for 298-59-9 / Methylphenidate Hydrochloride API manufacturers, exporters & distributors?

Methylphenidate Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Methylphenidate Hydrochloride

Synonyms

298-59-9, Centedrin, Centedrine, Methylphenidate hcl, Concerta, Ritalin

Cas Number

298-59-9

About Methylphenidate Hydrochloride

A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.

Methylphenidate Hydrochloride Manufacturers

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

Methylphenidate Hydrochloride Suppliers

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

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

Methylphenidate Hydrochloride KDMF

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

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

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

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

Methylphenidate Hydrochloride Manufacturers | Traders | Suppliers

Methylphenidate Hydrochloride Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Methylphenidate Hydrochloride

Get in contact with the supplier of your choice:

  1. Veranova
  2. Harman Finochem
  3. Ipca Laboratories
  4. Johnson & Johnson Innovative Medicine
  5. Mallinckrodt Pharmaceuticals
  6. SCI PHARMTECH
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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