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    Teva may get foreign CEO; FDA warns drug makers to check water systems

    Teva may get foreign CEO; FDA warns drug makers to check water systems

    This week, Phispers brings you an update on Teva’s continuing woes that include fines, plant closures and layoffs. With Laurus Labs’ Vizag unit clearing the US FDA inspection, we evaluate what Laurus’ expansion plans could mean for Mylan. And then there is some bad news on Pfizer, Amgen and AbbVie. While arthritis patients in Scotland sued Pfizer for its anti-inflammatory painkiller, Amgen suffered a setback over its osteoporosis drug and AbbVie’s Humira lost a patent battle. Read on.  Teva fined in India; may get foreign CEO; to shut down Hungary plant and layoff 500  Teva’s woes are continuing unabated. On Monday, India’s National Green Tribunal (NGT) slapped a fine of US$ 23,139 (INR 1.5 million) on Teva API India Limited for discharging untreated effluents into the Bagad river. The tribunal found the discharge from the sewage treatment plant of Teva API’s Gajraula-based plant in Uttar Pradesh to be below the permissible standards. Last month, the NGT had ordered closure of 13 industrial units in Uttar Pradesh, including the Gajraula plant of Teva API. Globally, the Israel-based generic giant may get a foreigner as its CEO. During a call with analysts recently, Teva’s chairman Sol Barer said: “We are looking around the world for the best candidate.” Teva’s CEO Erez Vigodman had stepped down in February this year. The company’s CFO Eyal Desheh has said he is resigning at the end of June. Teva’s Israeli board members are demanding that an Israeli be appointed CFO if the CEO is a foreigner. And then there is more trouble for Teva in Hungary. Last year, PharmaCompass had reported on Teva’s newly built sterile manufacturing facility in Godollo, Hungary, the issues highlighted by the FDA in its warning letter and the product recalls from this unit. Well, Teva is now winding up its sterile injectables plant in Godollo, and laying off 500 workers in the next few months. The plant had halted production last year after the FDA found manufacturing shortcomings. According to a Reuters report, Teva plans to close down or sell the Godollo plant by 2018-end. The company says its plans do not affect its other two Hungarian plants in Debrecen and Sajobabony. However, Teva isn’t the only one cutting jobs. Novartis announced it will cut 500 traditional production and development roles in Switzerland and another 250 job cuts are planned in the United States. This is part of Novartis’ global restructuring efforts. As G20 meets on antibiotic resistance, DSM wins an amoxicillin patent battle in India  Last week, health ministers of the G20 leading economies met for the first time and agreed to work together to combat issues such as a growing resistance to antibiotics. They also agreed on implementing national action plans by the end of 2018. According to the member countries, infectious diseases were spreading more quickly than before due to increased globalization. The 20 nations pledged to strengthen health systems and improve their ability to react to pandemics and other health risks. The results of the meeting will provide key inputs for a G20 leaders’ summit in Hamburg in July. A report last year found that newly resistant strains of bacteria were responsible for more than 25,000 deaths a year in the 28 member nations in the European Union. Meanwhile, the Delhi High Court granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement in India. This was announced by DSM Sinochem Pharmaceuticals (DSP), a leading company in the production and commercialization of sustainable, enzymatic antibiotics, next generation statins and anti-fungals, This patent, which is owned by DSP, relates to amoxicillin trihydrate having a low free water content and processes for the manufacture thereof. The permanent injunction prevents the manufacture, use, importation, offering for sale and sale of Weiqida’s amoxicillin trihydrate API in India, as well as any drug product that utilizes the API. Pfizer sued by 70 arthritis patients; study reveals safety risks after drug approvals  The world’s biggest pharma company Pfizer is being sued by 70 arthritis patients in Scotland, who say they were hit with terrible side effects from Celebrex, an anti-inflammatory painkiller touted as a wonder drug. The patients — both men and women in the age group of 60 to 90 years — are collectively seeking US$ 4.54 million (£3.5 million) in damages from the New York-headquartered pharma giant. They began taking Celebrex in 2002 to combat the effects of arthritis and muscle and joint stiffness. However, they went on to suffer health problems, including heart attacks and strokes. The Scottish patients hold good chances of winning the case. A recent study — titled Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010 — claims that almost a third of drugs cleared by the American regulator pose safety risks that are identified only after their approval. The study, that appeared in The Jama Network last week, says there is need for ongoing monitoring of new treatments years after they hit the market. Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (or 32 percent) were affected by a post-market safety event. Post-market safety events were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval, the study said. After Roche and AstraZeneca, Amgen suffers a setback on its osteoporosis drug  Earlier this month, both Roche and AstraZeneca had faced setbacks in the late-stage study of their drugs. Roche had reported its Tecentriq drug failed to significantly improve overall survival in a late-stage bladder cancer study. And an experimental biotech drug for severe asthma from AstraZeneca failed to meet its goal of significantly reducing attacks in a late-stage study. As if to continue the trend, last week Amgen’s top-stage drug prospect aimed at treatment of osteoporosis — romosozumab — faced some serious setbacks. What initially seemed like happy news — that the late-stage trial comparing romosozumab to Fosamax hit its primary and key secondary endpoints — turned into some serious questions about the future of romosozamub.  The first big setback was a prominent cardio risk imbalance between romosozumab and Fosamax — 2.5 percent for romosozumab and 1.9 percent for Fosamax. The second big setback came from the FDA, which wants to evaluate the new set of head-to-head data before approving romosozumab. And that means no decision is expected this summer! Humira loses key patent battle as J&J tries to block Samsung’s Remicade biosimilar  AbbVie’s Humira — the world’s best selling drug which is a treatment for rheumatoid arthritis — received a setback when the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) handed down a verdict in favor of Coherus BioSciences, a biopharma company in the US.  The verdict struck down AbbVie’s ‘135 methods patent on Humira after an inter partes review. The patent had been labelled as a shield and “one of the cornerstones of the Humira IP estate,” by Barclays analysts. However, all IPR decisions are subject to appeal. In a statement, AbbVie said it does plan to appeal against the verdict. Meanwhile, a unit of Johnson & Johnson filed a lawsuit to block the sale of a copy of its rheumatoid arthritis drug Remicade made by South Korea's Samsung Bioepis in the US. Remicade is J&J’s biggest selling drug, with US sales of about US$ 5 billion a year. Through the law suit, the J&J company — Janssen Biotech Inc — has sought a preliminary or permanent injunction to block Samsung Bioepis' biosimilar of Remicade, from sale in the US. Frontida BioPharm gets FDA’s ‘all clear’ for Philadelphia plant bought from Sun  In June last year, Frontida BioPharm had bought Sun Pharmaceuticals’ finished pharmaceutical plant in Philadelphia. And barely eight months back, it received an FDA warning letter for this plant, based on an inspection that took place in 2015. The warning letter had mentioned that Sun Pharma’s quality unit at the time had knowingly released 27 lots of various strengths of clonidine HCl tablets, despite evidence that the API used in manufacturing was potentially contaminated. The warning letter had been issued in August 2016, and Frontida knew about the regulatory issues when it acquired the facilities last year from Sun Pharma, India’s largest drugmaker. The good news is that Frontida BioPharm says the US FDA has given the plant an all-clear. Frontida says Sun helped it address these issues. With the regulatory issues behind it, Frontida can now move forward with its expansion plans. “The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market,” Frontida CEO Song Li said in a statement. FDA warns drug makers to check water systems for BCC contamination  The US FDA has warned manufacturers of non-sterile, water-based drug products of Burkholderia cepacia complex (BCC or B cepacia) contamination, as there have been recent product recalls due to this and other water-borne opportunistic pathogens found in pharmaceutical water systems. The regulator’s warning stems from multi-state outbreak of infections. In March this year, Phispers had carried a news item on Badrivishal Chemicals & Pharmaceuticals, a manufacturer of docusate sodium. It had been placed on FDA’s import alert list in December last. The FDA warning letter issued to Badrivishal talks about adulteration with BCC. The facility used water as a drug component and for cleaning the facility and equipment. The water source was a river in the vicinity which passes through farmland, where it is subject to agricultural runoff and animal waste, before it reaches the Badrivishal manufacturing site. FDA’s concern was that contaminated water has been the root cause of multi-state outbreak of infections and multiple recalls by other drug manufacturers of non-sterile liquids, including instances of adulteration with BCC. “BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” the FDA said. Detecting BCC bacteria is a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. Laurus Labs to enter the US generics market; how will this impact Mylan?  Last week, Laurus Labs announced that its API facility at Unit 2 in Vizag (India) cleared the US FDA inspection without any Form 483 observations. The unit manufactures APIs and finished dosage formulations (FDFs). This successful inspection will help the company as it plans to foray into the highly regulated US generics market. Does this suggest trouble for US generic drug giant Mylan? We think so. Laurus was started by Dr Satyanarayana Chava in 2007, and is a key manufacturer and supplier of APIs. With almost US $ 300 million in revenues, it holds its own against better-known competitors like Mylan. In fact, Laurus and Mylan have a lot in common. Both the companies are headed by men who worked together at Matrix Laboratories. Mylan acquired a controlling stake in Matrix around the time Chava founded Laurus Labs. Until then, Chava was the chief operating officer of Matrix, which was being headed by Rajiv Malik, the current president of Mylan. Laurus has also carved a niche for itself by supplying antiretroviral or ARVs (used to fight infections caused by retroviruses like HIV), hepatitis C and oncology drugs. And despite being a relatively new player, its clients include giants like Pfizer, Teva and Merck. APIs generally make up for 20 to 35 percent of the total cost of a drug, but the ones that Laurus develops, like ARVs, constitute 70 to 75 percent of the cost of the drug. Both companies have a stronghold in the treatment of AIDS. Globally, Laurus has achieved a leadership in the manufacture of ARV APIs. And in the case of Mylan, nearly 50 percent of patients receiving treatment for HIV/AIDS in the developing world rely on its product, all of which are made in India. In fact, Mylan is India's third largest pharmaceutical exporter. So seems like Mylan should watch out for Laurus as it forward integrates into making finished formulations. Laurus recently filed 2 Abbreviated New Drug Applications in the United States and submitted a dossier to the WHO (World Health Organization).  

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    https://www.pharmacompass.com/radio-compass-blog/teva-may-get-foreign-ceo-fda-warns-drug-makers-to-check-water-systems

    #Phispers by PHARMACOMPASS
    25 May 2017
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    FDA issues warning letter to recently sold Sun Pharma facility over drug contamination concerns

    FDA issues warning letter to recently sold Sun Pharma facility over drug contamination concerns

    Two months ago, “as a part of its manufacturing consolidation in the US”, Sun Pharmaceuticals announced the sale of two facilities located at Philadelphia, Pennsylvania and Aurora, Illinois to Frontida Biopharm.  In the announcement , Sun Pharma never mentioned that an inspection by the U.S. FDA, from June 15 to July 17, 2015, had raised serious concerns about the compliance standards at the Pennsylvania site. A recently posted warning letter, issued to the Pennsylvania site, mentions that Sun Pharma’s quality unit, at the time, had knowingly released 27 lots of various strengths of clonidine HCl tablets, despite evidence that the active pharmaceutical ingredient (API) used in manufacturing was potentially contaminated. During the inspection, Sun Pharma’s vice president of quality repeatedly denied any knowledge of a recall of the contaminated clonidine HCl by the API supplier, “even though e­mail evidence collected during the inspection showed that this individual had been notified of the recall as early as July 16, 2014”. Sun Pharma removed the individual from his position during the course of the inspection.FDA investigators also found that the firm had failed to take necessary corrective measures even though they were aware that impurities, from the ink and varnish on the primary container labels, had leached into the tablets. Integration challenges at Sun PharmaThe warning letter posting on the FDA Website coincides with Sun Pharma’s Managing Director, Dilip Shanghvi acknowledging the challenges associated with the integration of its acquisition of Ranbaxy.In the company's Annual Report for 2015-16, he said, "We are gradually progressing on the remediation process at the erstwhile Ranbaxy facilities, which were found to be non-compliant in the past. While significant efforts to make these facilities compliant are on, this will be a time-consuming process" He further went on to add, "Over the past year, our cGMP capabilities have been strengthened significantly. Talent with long-standing global expertise has enhanced our abilities in this pertinent area. We are also targeting appropriate technology-based solutions to facilitate cGMP compliance, coupled with an increased focus on requisite manpower training." Our viewSun Pharma’s daring bet to acquire Ranbaxy has always been considered a high risk investment in view of the troubled state of compliance at Ranbaxy. In the past year, Sun Pharma has run into its own compliance problems at its Halol facility, which contributed almost 20 to 25 percent to Sun's profits in 2014. At the time of the Ranbaxy deal, Dilip Shanghvi, the founder of Sun Pharma said the primary focus would be to comply with regulatory standards and make Ranbaxy healthy “before jumping into the business priorities”. However, it now remains to be seen if Sun Pharma will continue to focus on turning around their troubled operations or divest their way out of problems.     

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    https://www.pharmacompass.com/radio-compass-blog/fda-issues-warning-letter-to-recently-sold-sun-pharma-facility-over-drug-contamination-concerns

    #Phispers by PHARMACOMPASS
    25 Aug 2016
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    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

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    https://www.pharmacompass.com/radio-compass-blog/gsk-google-form-first-bioelectronics-firm-11-generic-companies-benefit-from-the-teva-allergan-deal

    #Phispers by PHARMACOMPASS
    04 Aug 2016
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