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Amman Pharmaceutical Industries API

Amman Pharmaceutical Industries (API) was established in 1989 as one of the first pharmaceutical companies in the MENA region
FDA approval of amman Pharma

This is a top achievement for Amman Pharma

Amman, April xxx 2022 Amman Pharmaceutical Industries (‘AMMAN PHARMA’), a leading pharmaceutical company and contract developing & manufacturing organization (CDMO) operating FDA Drug & Medical Device listed establishments facility and a drug exporter to the United States of America earns NSF/ANSI 455-4 Good Manufacturing Practice Certification for its drugs and medical device manufacturing facilities in Amman, Jordan. This certification is issued only after extensive material and facility analysis and gives suppliers, retailers, regulators, and consumers assurance that products manufactured by Amman Pharma meet the highest standards for safety, quality, sustainability, and performance required by the US Food & Drug Administration (FDA).

Good Manufacturing Practices (GMPs) are guidelines that provide a system of processes, procedures, and documentation. These GMP requirements are listed in NSF/ANSI 455-4 GMP standard which is developed by the OTCs industry in accordance with 21 CFR Part 210 and 21 CFR Part 211.

AMMAN PHARMA has become one of the first pharmaceutical and medical device manufacturers in the MENA region to have FDA Drug Establishment Number and Medical Device Establishment number and to receive an NSF/ANSI 455-4 Good Manufacturing Practices (GMP) certification from the highly selective global public health and safety organization NSF International.

“With the NSF/ANSI 455-4 OTC drug GMP certification, consumers can be confident that our products meet strict GMP standards required by the US FDA” said Dr. Fadi Al Atrash, Amman Pharma General Manager “Achieving the highest grade possible ‘A’ during NSF’s review is a testament to the high standards to which we hold our quality management processes and importantly, it puts Amman Pharma on par with the leading pharmaceutical manufacturers in the US and worldwide.”

About NSF International:

NSF International is an independent, global organization that writes standards, and tests and certifies products for the health sciences, food, water and consumer goods industries to minimize adverse health effects and protect the environment. With operations in more than 175 countries, NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.

About Amman Pharmaceutical Industries:

Amman Pharmaceutical Industries (‘AMMAN PHARMA’) was established in 1989 as one of the first pharmaceutical companies in the MENA region to pioneer the production of niche branded generics in the therapeutic areas of Ophthalmology, ENT & Respiratory, Dermatology, and Oral Liquid Preparations. Headquartered in Jordan, AMMAN PHARMA produces more than 150 diverse products, offers CDMO services, and serves more than 30 markets globally across the United States, Europe, Middle East and Africa, and Central Asia. Some of our US products can be found on Dailymed including https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=human&query=octiq&pagesize=200&page=1 and https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ddb9359e-2fc4-4ce3-a7d2-027b17f01161.

For more information, please visit: www.ammanpharma.com and www.ammanpharmausa.com

Contact:

Dr. Fadi Al Atrash
General Manager
Amman Pharmaceutical Industries
Tel: +962 6 4023072
Email: Fadi@ammanpharma.com

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