United States, 19th Dec 2022, King NewsWire – In 1995 at the Hair Replacement Surgery Seminar, the president of the international Hair Loss Council, began discussing the need for a certifying board in both surgical (hair restoration surgery) and nonsurgical hair replacement (hair attachment and hair systems). Around this time, the Federal Trade Commission began reviewing cosmetic claims regarding surgical and nonsurgical hair restoration. With the realization that if professionals did not police their profession that the government would interfere and mandate onerous rules and restrictions, the decision was made to present a detailed plan for forming two boards: one for surgeons performing hair transplantation and the other for nonsurgical hair replacement technicians.
The product lines were born out of several investigational and clinical trials by the International Association of Hair Transplant Surgery Organizations and the Board of Hair Restoration Surgery on patients and were found to be effective and 60% equivalent to surgical intervention. The research studies conducted on hair loss patients confirmed not all hair loss is caused by DHT over-production, the board created these products differently from traditional basic minoxidil solutions. The goal is to keep patients healthier and off medication in the shortest possible time, by birthing a pathway of broad-spectrum hair loss treatment that would cover all likely causes of hair loss. After long clinical studies, proof has been established that using Minoxidil alone is not a solution to hair loss, because when discontinued, the hair loss continues. This would mean lifetime dependence on treatment to keep the hair, hence these product formulas were combined with another active ingredient that treats other causes of hair loss present in 70% women such as-inflammatory scalp and scarring Cicatricial alopecia, follicular degeneration syndrome, and clogged pores.
In June 1996, the organizational meeting for a hair replacement surgery certification examination was held at New York. At the culmination of this meeting, the International Board of Hair Restoration Surgery was created. Each of the societies represented at this meeting agreed that their organization would accept and recognize this board as the only board certification focusing strictly on hair restoration surgery.
The plans for surgical hair restoration and nonsurgical hair replacement were submitted to the board of directors of the AHLC. The board accepted the proposal and offered to sponsor an organizational meeting with the leaders in the field of hair restoration surgery. The board did not accept the proposal for a nonsurgical hair replacement certification at the time since they believed such an endeavor would be too divisive and exclusionary for their members. But after series of miraculous results from these non-surgical interventions, approval was granted and then submitted to the federal regulatory authorities for approval.
With the financial backing of the AHLC, invitation letters were sent to the presidents of all the physician organizations whose members perform hair restoration surgery: the International Society for Hair Restoration Surgery (ISHRS), the World Association for Hair Restoration Surgery (WAHRS), the American Academy of Facial Plastic & Reconstructive Surgery (AAFPRS), the American Academy of Cosmetic Surgery (AACS), and the American Hair Loss Council (AHLC). Each organization or society was asked to discuss the format, logistics, and financial commitment to form a certifying board in hair restoration surgery to fund non-surgical treatment line.
Finding a suitable laboratory with the necessary infrastructure, knowledge, and skills in pharmaceutical sciences was the next challenge the committee encountered. After visiting dozens of laboratories in the United States and Canada, they concluded AmWiner Raphe Pharmaceutique laboratories in Dallas, Texas, would be the laboratory home for these product lines. AmWiner being the southeast vendor for Johnson and Johnson, gave them more confidence, and for having gained the recognition of Perrigo. The expertise of their Compounding pharmacists and chemists made them the top on the list for the manufacturing of these science base hair loss treatments. In 2008, the board formed a joint ownership with AmWiner Raphe Pharmaceutique laboratories.
These non-surgical hair loss product treatments have been tested by all the organizations and now used mainly at the medical offices treating hair loss surgically and non-surgical. The plan is to offer them as private label to clinician and medical practitioners with 3% of sale profit donated back to the organization for continual research on hair loss.
Their manufacturing site in Dallas Texas manufactures about 4.5M tablets and capsules and 850k bottles of liquid hair loss treatment solutions monthly, supporting millions of patients all over the world. The site offers expertise in oral solid and liquid product development, flexible volume manufacturing, leading packaging technologies, and global delivery. Dallas stands out as one of their most future-oriented and digitally enabled pharmaceutical production sites with industry 4.0 digital processes and state of art technologies, computer integrated manufacturing and fully automated process and material flow.
Company Name: AmWiner Raphe Pharmaceutique Laboratories
Contact Person: Mitch Rapheal
Email: [email protected]
Country: United States
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