Vamsi labs Formoterol Fumarate Vamsi labs Formoterol Fumarate

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

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Flag Spain
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Samo Pharmaceutical Co., Ltd.
2013-08-19
20130819-187-I-288-06
INKE S.A.
Spain
Argent,1, Area Industrial...
Flag India
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Aging Life Science Co., Ltd.
2018-10-24
20160310-187-I-468-08(2)
Aarti Industries Limited
India
Unit-IV, Plot No. E-50, M...
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Aging Life Science Co., Ltd.
2016-03-10
20160310-187-I-468-08
Aarti Industries Limited.
India
Unit-IV, Plot No. E-50, M...
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Kookjeon Pharmaceutical Co., Ltd.
2017-09-01
20160310-187-I-468-08(1)
Aarti Industries Limited.
India
Unit-IV, Plot No. E-50, M...
Flag United Kingdom
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AstraZeneca Korea Co., Ltd.
2012-09-06
20120906-187-I-61-02
AstraZeneca AB
Sweden
Forskargatan 18, Sodertal...
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Kolon Pharmaceutical Co., Ltd.
2018-06-14
20180420-187-I-540-09(1)-A
Industriale Chimica Srl
Italy
via EH Grieg 13 21047 SAR...
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Korea Menarini Co., Ltd.
2019-09-18
20180420-187-I-540-09(2)
INDUSTRIALE CHIMICA srl
Italy
via EH Grieg 13 21047 SAR...
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Samo Pharmaceutical Co., Ltd.
2013-04-18
20130418-187-I-191-05
Lusochimica SpA@IMS srl (...
Italy
Lomagna Plant, Via Giotto...
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Yuyu Pharmaceutical Co., Ltd.
2022-09-26
20220926-187-I-648-10
Lusochimica SpA@IMS srl@N...
Italy
Via Giotto 9, 23871 Lomag...
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Handok Teva Co., Ltd.
2015-06-02
20150226-187-I-450-07(1)
Sicor Societa' Italiana C...
Italy
Via Terrazzano, 77-20017 ...
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SPC Korea Co., Ltd.
2015-02-26
20150226-187-I-450-07
SICOR SOCIETA'ITALIANA CO...
Italy
Rho(MI) - Via Terrazzano,...
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ST Pharm Co., Ltd.
2012-12-07
20121207-187-I-281-04
ST Pharm Co., Ltd.
South Korea
231 Hyeopjeong-ro, Siheun...
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Ace Biopharm Co., Ltd.
2011-12-02
20111202-187-I-22-11
Mylan Laboratories Limite...
India
Plot No. 1A/2, MIDC Indus...
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  • POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH
  • AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH
  • AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH
  • AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH
  • AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH
  • AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

Looking for / Formoterol Fumarate API manufacturers, exporters & distributors?

Formoterol Fumarate manufacturers, exporters & distributors 1

50

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

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

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

API | Excipient name

Formoterol Fumarate

Synonyms

Mls001401438, Chembl1895091, Hms2051p14, Hms2233m10, Ccg-101038, Nc00288

Dulera Manufacturers

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

Dulera Suppliers

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

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

Dulera KDMF

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

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

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

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

Dulera Manufacturers | Traders | Suppliers

Dulera Manufacturers, Traders, Suppliers 1
36

We have 8 companies offering Dulera

Get in contact with the supplier of your choice:

  1. Inke S.A
  2. Aarti Pharmalabs
  3. AstraZeneca
  4. Industriale Chimica s.r.l.
  5. Lusochimica SPA
  6. Sicor Societa Italiana Corticosteroidi Srl
  7. ST Pharma
  8. Viatris
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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