Temazepam

None Ankleshwar, India – July 22, 2024 – RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company based in India specializing in the area of addiction treatment and pain management, recently announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Practice (GMP) approval for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India). The approval, received on May 29, 2024, followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024. This milestone marks a significant achievement for the company as it paves the way for it to enter the US API market. With an active US Drug Master File (DMF) for niche APIs like Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride, Rusan Pharma plans to expand its portfolio with additional APIs, including Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam. Speaking on the achievement, Dr. Kunal Saxena, Managing Director of Rusan Pharma, highlights, "This GMP approval by the USFDA underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instils confidence in our partners and clients, reassuring them of our dedication to excellence in producing high-quality APIs that meet the most stringent global standards.”  The USFDA approval of the Ankleshwar facility is a critical development in Rusan Pharma's strategy to become a key player in the global pharmaceutical industry. Currently, the company supplies APIs to various US-based companies focused on orphan drugs, addiction treatment, and obesity medications. The approval will further enhance Rusan's capabilities, expand its API product portfolio, and increase its footprint in the growing US pharmaceutical sector. Following on-site audits, Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies such as Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan implemented 21-CFR-compliant software solutions like SAP, Laboratory Information Management System (LIMS), document & quality management systems (DMS & QMS) and electronic logbooks, ensuring a move towards paperless manufacturing. This transition, along with comprehensive staff training and monitoring, posed significant challenges that the company successfully overcame. Before receiving this approval, Rusan Pharma established a robust presence in key markets such as Australia, Brazil, Canada, EU, Mexico, New Zealand, and the United Kingdom. The USFDA's endorsement enables the company to market its APIs to US clients with existing marketing authorizations and those developing new formulations. This approval further bolsters our customers' and regulatory agencies' trust and confidence in us globally. "Our vision is to be a one-stop solution provider in the niche category of addiction treatment and pain management. Integration with API enables us to remain competitive, while promoting our finished formulation in the global market. It also enables us to be independent from other companies for the supply of critical APIs for manufacturing of various finished formulations, especially for narcotic and psychotropic products. Timely delivery of quality medicine is key to any pharmaceutical business. Hence, a robust supply of API enables us to achieve a rapid time to market with critical products" adds Dr Kunal Saxena.  Rusan’s Ankleshwar manufacturing unit’s strategic role in its manufacturing and distribution network is underscored by its focus on critical APIs like fentanyl and buprenorphine. The company's vision is to be a comprehensive addiction treatment and pain management provider, ensuring competitive and timely delivery of quality medicines. In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ (Madhya Pradesh, India) with an annual production capacity of upto 400 MT, which is significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection of this new facility by the USFDA and other international inspecting agencies. This expansion aims to boost Rusan's manufacturing capabilities. About Rusan Pharma Pvt Ltd:  Rusan Pharma Pvt Ltd. is an integrated global pharmaceutical company and market leader that specializes in the treatment of Addiction and Pain Management. They offer a complete range of super-specialized products in India and globally. Rusan indigenously develops, manufactures, and markets novel APIs and finished formulations and is one of the few notified companies, which is allowed imports of Narcotic Raw Materials (NRM) such as Thebaine, Oripavine, Codeine and Morphine for the purpose of manufacturing various APIs and finished formulation in India and then re-exporting to global markets. Over the years, Rusan has closely worked with Indian and global institutions such as NACO, UNODC, UNOPS, Global Fund, and Ministries of Health to launch Opioid Substitution Therapy in various emerging markets. Rusan Pharma’s strength lies in innovation of New Drug Delivery Systems (NDDS) such as transdermal patches, implants, depot injections. Rusan was the first company to launch Fentanyl, Buprenorphine and Nicotine Transdermal Patches in India. The company supplies range of products to countries such as India, Canada, Europe, UK, Russia, CIS, South Africa and other South-East Asian countries. Rusan’s API and finished formulation manufacturing facilities hold GMP accreditations such as USFDA, Health Canada, EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S (UKRAINE), ANVISA (Brazil) UAE and many more.

WASHINGTON, Dec 12 (Reuters) - A crackdown by U.S. drug wholesalers in response to the opioid crisis is preventing some pharmacists from dispensing a combination of stimulants and sedatives routinely prescribed by psychiatrists to help patients manage conditions like anxiety and ADHD. The three main U.S. pharmaceutical wholesalers - AmerisourceBergen Corp (ABC.N) , Cardinal Health Inc (CAH.N) and McKesson Corp (MCK.N) - tightened monitoring of suspicious orders from pharmacies in July as part of a $21 billion nationwide opioid settlement with attorneys general from 46 states, the District of Columbia, and five territories. Five independent pharmacists in five different U.S. states told Reuters that in recent months they were notified by the wholesalers that they would be cut off from the distribution of all controlled substances after filling prescriptions for psychiatric drugs such as the stimulant Adderall - used to treat attention deficit hyperactivity disorder (ADHD) - and anti-anxiety drug Xanax. The pharmacists spoke on condition of anonymity for fear of harming their businesses. These psychiatric drugs are regulated by the federal government as controlled substances that have high potential for abuse and addiction but are not opioids. The wholesalers imposed the bans because the pharmacies had filled prescriptions written by medical practitioners who frequently prescribed controlled substances or had filled prescriptions assigning both a stimulant and a sedative to the same patient, according to interviews with the pharmacists and letters from AmerisourceBergen to one of the pharmacies, seen by Reuters. The U.S. Drug Enforcement Administration (DEA) identifies combination prescriptions of stimulants and sedatives as a red flag in its guidance to pharmacies on illicit drug use. Three psychiatrists interviewed by Reuters described such combination prescriptions as medically valid and dispensed routinely for years to manage comorbidities or address stimulant side-effects like insomnia. Comorbidity refers to the simultaneous presence of two or more diseases or medical conditions in a patient. An ADHD patient taking Adderall to focus during the day may need the sedative temazepam to sleep at night, or clonazepam to treat anxiety, the psychiatrists said. ADHD and anxiety disorders are among the most common psychiatric disorders and have a 25% comorbidity rate with each other. Matthew Goldenberg, president-elect of the Southern California Psychiatric Society, a chapter of the American Psychiatric Association, said some members had complained that pharmacies were no longer comfortable filling combination prescriptions for controlled substances because of concern they could be blacklisted. "This is detrimental potentially to many patients who have comorbid anxieties along with ADHD, or sleep issues along with ADHD," he told Reuters. "I think it's a trickle-down effect from the opiates." The impact on independent pharmacies' prescriptions of psychiatric drugs from the widening crackdown on opioids has not been previously reported. There are just over 19,400 independent pharmacies in the United States, representing just over one-third of all retail pharmacies, according to the National Community Pharmacists Association (NCPA). The five pharmacists interviewed by Reuters said wholesalers' bans on supplies of controlled substances threatened the viability of independent pharmacies while letting chains like CVS Health Corp (CVS.N) and Walgreens Boots Alliance Inc off the hook. CVS, the biggest U.S. pharmacy chain, did not respond to requests for comment for this story. Walgreens, the largest shareholder in AmerisourceBergen, declined to comment. Reuters was unable to determine to what degree the chains have been impacted by the enhanced monitoring. The U.S. opioid crisis has caused nearly 650,000 overdose deaths since 1999 and is continuing to worsen, according to federal government data. Over the past two years, the three drug wholesalers agreed to a series of settlements totalling billions of dollars following accusations they fueled the opioid crisis by turning a blind eye to high-volume prescribers and "pill mills" that supplied addicts rather than patients. The companies have denied any wrongdoing. Under pressure from regulators, lawmakers and judicial authorities, the wholesalers developed algorithms to detect suspicious prescribing patterns for opioids such as oxycodone and fentanyl, both used medically as painkillers. They said publicly that they’ve enhanced that monitoring this year. AmerisourceBergen's Vice President for External and Executive Communications Lauren Esposito said the company maintains a "robust" program to monitor and halt suspicious orders of all controlled substances. It is dedicated to mitigating the abuse of controlled substances without interfering in good-faith clinical decisions made by doctors, she said. "Pharmaceutical distributors must walk a legal and ethical tightrope between providing access to necessary medications and acting to prevent diversion of controlled substances," Esposito said in a written statement. "We continue to advocate for greater clarity and regulatory guidance on the matter." Cardinal Health and McKesson did not respond to requests for comment. The SUPPORT Act of 2018, designed to tackle the opioid epidemic, required the DEA to implement a program with distributors to record suspicious orders of controlled substances and to share that information with state governments. It also mandated the DEA and the U.S. Food and Drug Administration (FDA) to provide guidance to pharmacies on suspicious orders. The DEA, in response to Reuters' questions, said it does not "participate in the practice of medicine" and does not determine what would constitute an "antagonistic combination" of drugs. A spokesperson for the FDA said that in general it does not regulate the practice of medicine and cited National Institute on Drug Abuse (NIDA) guidance that stimulants should not be used with other medications unless recommended by a physician. Daniel, a 37-year-old California-based private equity executive, said he has been forced to ration Adderall twice in the past two months because his pharmacy either asked him to delay filling a combination prescription or to fill it partially elsewhere amid concerns that the dispensary might be blacklisted by wholesalers. Daniel, who declined to give his last name over medical privacy concerns, said his pharmacist had asked to just dispense his Klonopin, prescribed for anxiety, and for him to fill his Adderall prescription elsewhere so that the pharmacy would not get in trouble. He declined to identify the pharmacy. "I'm the president of a company. I need to confidently make decisions, and anxiety is not something that allows that to happen," he told Reuters. Psychiatrists said the problem for some patients has been compounded by a nationwide shortage of Adderall in recent months due to manufacturing delays at Teva Pharmaceutical Industries Ltd (TEVA.TA) , the Israel-based company that produces it. Teva said that, in addition to the production issues, there had been a "significant rise" in national prescription rates for the drug. "If you're on a dose of Adderall and you stop it, you can feel terrible," said Eric Levander, a Los Angeles psychiatrist, who said at least five of his patients have been unable to fill their prescriptions at multiple pharmacies because of the crackdown. Aside from the medical drawbacks, patients run the risk of being flagged as suspicious in state Prescription Drug Monitoring Program (PDMP) databases – which are accessible by law enforcement - for attempting to fill prescriptions in several places, he said. ‘Pharmacy shopping’, if it entails attempting to obtain a narcotic by fraudulent means, is typically a felony and can result in a heavy fines or jail time. "I had a patient run out of his stimulant medication for a few days, and he was depressed for a week afterwards and screwed up on his exams," Levander said. AmerisourceBergen had informed clients in March that changes to its Controlled Substance Monitoring Program (CSMP) would kick in from July 1 as a result of the nationwide settlement, a presentation made public by the company showed. AmerisourceBergen predicted a higher number of orders would be flagged as suspicious. Previously, the company reviewed suspicious orders and then either approved or cancelled the shipments but it said that under the new system such orders would be canceled automatically and reported to regulators without review. AmerisourceBergen said all three wholesalers were subject to the exact same requirements. Anne Burns, vice-president of the American Pharmacist Association (APhA), said that, while wholesalers had initially focused their monitoring on opioid orders, they have increased their scrutiny of stimulants following a rise in the illicit market for them. Reports from pharmacies across the country suggested the focus was spreading to other controlled substances as well, she added. "We've really been pushing the DEA and wholesalers ... be more transparent on how these decisions are made, about what the pharmacy is able to order or not," Burns said. The pharmacists interviewed by Reuters said they had received no clear rules on which drug combinations are problematic nor the ratio of controlled substances as a proportion of total prescriptions deemed suspicious. The pharmacy owners interviewed by Reuters in California, New York, Florida, Iowa and Kansas described a near-identical pattern for the three wholesalers. Firstly, individual orders would be denied without explanation, followed by a letter from the wholesaler suspending orders of any controlled substance for a year, citing red flags like suspicious combinations of drugs or filling prescriptions from medical practitioners who prescribe too many controlled substances. Then, pharmacies were given a window to appeal that decision but then told within a month their response was not satisfactory and the ban on orders of controlled substances would stand. "It's a real challenge for smaller pharmacies to defend themselves against this kind of behavior," said Al Harris, lawyer for Ken's Sunflower Pharmacy in Kansas. The pharmacy sued AmerisourceBergen for breach of contract after it banned Sunflower in June from ordering controlled substances, saying it filled prescriptions written by a doctor prescribing too many controlled substances and filled too many prescriptions containing 'antagonistic combinations'. "My client is not diverting oxycodone under the streets," said Harris. "He's a small pharmacy, and they can crack down on him with nearly no financial detriment to themselves." AmerisourceBergen said its diversion control program applied to all orders across all companies – regardless of chain or independent affiliation. Our Standards: The Thomson Reuters Trust Principles. Thomson Reuters Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.