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The human placenta, as a raw material for the preparation of medicines, constitutes a starting material of biological origin, which is why it is subject to compliance with specific requirements for this type of production, taking into account the characteristics of its origin and the inherent risk. to the transmission of infectious diseases.
The production of medicines requires a demanding quality policy with the aim of safeguarding the interests of patients, society and the State, so the obtaining and use of the human placenta as a pharmaceutical raw material requires to be regulated and to be subject to the control of the drug regulatory authorities, which in the Cuban sphere is instituted by the Center for State Control of Medicines, Medical Equipment and Devices (CECMED).
Our company has established, with the Cuban Public Health System, a Human Placenta Collection Program in the country’s gynecological-obstetric hospitals. Through Regulation M 02 – 18 issued by the State Center for the Control of Medicines and Medical Devices (CECMED) “Human Placenta as a pharmaceutical raw material” the requirements for the process of obtaining placentas are established, from the selection and control of the donors until their delivery to the producing entity. It constitutes the update of the CECMED Regulation 2/2002, Human placenta as a pharmaceutical raw material, taking into account the experience accumulated by several institutions in the country, as well as the internationally established practice for organ donation.
The human placentas collected and transferred to the Production Plant under refrigeration conditions, come from healthy women; and are subjected to strict controls, which guarantee biological safety.
The necessary equipment for the storage and thawing of placentas is concentrated in the Production Plant; extraction and processing of the different placental extracts, as well as the packaging and storage of the finished products for their subsequent distribution.
The finished products are subjected to strict physical-chemical, biological and microbiological controls to confirm their quality, efficacy and safety.
Medicines, cosmetics, nutrients and other products in development constitute the product portfolio of the Center for Placental Histotherapy “Dr. Carlos Manuel Miyares Cao”.
The EMCOMED company is in charge of the distribution in the country of finished products destined for National Consumption and the FARMACUBA company is in charge of marketing abroad; Both companies belong to the Cuban Biotechnological and Pharmaceutical Industries Group. BioCubaFarma.
1414, 43 th st, Miramar. Playa. Havana. Cuba.
Phone: (537) 72152198
If you want to know our latest scientific-technical results and other news corresponding to 2022, we suggest you download Bulletin Number 1 of 2023 “We continue to grow”.
Placental Histotherapy Center “Dr. Carlos Manuel Miyares Cao”.
All rights reserved. 2022