
Hyderabad (Telangana) [India], October 09: Optimus Pharma Private Limited today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for the generic equivalent of Rexulti® Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical Co., Ltd. Optimus Pharma’s approval for its Abbreviated New Drug Application (ANDA) BREXPIPRAZOLE Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, was received on October 8th, 2021. BREXPIPRAZOLE will be manufactured at Optimus Pharma’s Pashmylaram USFDA accredited facility in India.
BREXPIPRAZOLE Tablets (RLD: Rexulti® Tablets) had estimated annual sales of USD 1258 million in the U.S. (IQVIA MAT July 2021).
BREXPIPRAZOLE has a favourable antipsychotic profile in terms of improvement of cognitive performance and sleep patterns, as well as effects on affective states and potential to treat core symptoms in schizophrenia and major depressive disorder, including cognitive deficits with a low risk of adverse effects (extrapyramidal symptoms, metabolic complications, weight gain, akathisia potential) that are commonly encountered with other typical and second-generation antipsychotic drugs. From the studies done so far, it can be concluded that BREXPIPRAZOLE can be effective monotherapy for schizophrenia and as an adjunct to other antidepressant medications in major depressive disorder.
About Optimus Pharma
Optimus was established in the year 2004 as a custom synthesis laboratory by a team of techno-commercial experts. It is one of the fastest-growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and Finished dosages. Over the last decade, we have been certified and audited by reputed Global Regulatory Agencies like USFDA, WHO, COFEPRIS, EMA, KFDA and AFM from PMDA Japan. Optimus Pharma is a vertically integrated pharmaceutical company engaged in the manufacturing of Solid Oral and semisolid formulations. We have successfully integrated our API and Formulation R&D teams, with the IP and Regulatory Affairs team in order to ensure a dynamic product portfolio. We help our customers serve global markets with technology based, innovative, cost effective & consumer friendly products of the highest quality.
Real instructive and great body structure of articles, now that’s user genial (:.
F*ckin’ tremendous issues here. I’m very happy to peer your article. Thanks a lot and i am taking a look forward to contact you. Will you kindly drop me a e-mail?
Thanks for another magnificent post. Where else may anybody get that type of info in such a perfect manner of writing? I’ve a presentation subsequent week, and I’m at the look for such info.
superb post.Ne’er knew this, regards for letting me know.
You are my breathing in, I possess few blogs and often run out from brand :). “‘Tis the most tender part of love, each other to forgive.” by John Sheffield.
you’re really a good webmaster. The web site loading speed is amazing. It seems that you are doing any unique trick. Also, The contents are masterpiece. you have done a wonderful job on this topic!
Today, I went to the beach with my children. I found a sea shell and gave it to my 4 year old daughter and said “You can hear the ocean if you put this to your ear.” She placed the shell to her ear and screamed. There was a hermit crab inside and it pinched her ear. She never wants to go back! LoL I know this is totally off topic but I had to tell someone!
I just could not depart your website before suggesting that I extremely enjoyed the standard info a person provide for your visitors? Is gonna be back often in order to check up on new posts
whoah this blog is great i love studying your articles. Keep up the good work! You know, many people are hunting round for this info, you can aid them greatly.
Only a smiling visitor here to share the love (:, btw great design. “The price one pays for pursuing a profession, or calling, is an intimate knowledge of its ugly side.” by James Arthur Baldwin.
great points altogether, you simply gained a brand new reader. What would you recommend about your post that you made some days ago? Any positive?
I like what you guys are up also. Such clever work and reporting! Keep up the superb works guys I?¦ve incorporated you guys to my blogroll. I think it will improve the value of my web site 🙂
WONDERFUL Post.thanks for share..more wait .. …
Your house is valueble for me. Thanks!…
Good day! I know this is kind of off topic but I was wondering if you knew where I could get a captcha plugin for my comment form? I’m using the same blog platform as yours and I’m having trouble finding one? Thanks a lot!
I always was interested in this subject and stock still am, thankyou for posting.
Respect to article author, some superb entropy.
whoah this blog is great i love reading your posts. Keep up the great work! You know, lots of people are hunting around for this information, you could aid them greatly.
Your home is valueble for me. Thanks!…
You have noted very interesting points! ps nice site.
I went over this website and I think you have a lot of superb info, saved to fav (:.
Very well written post. It will be beneficial to everyone who employess it, as well as myself. Keep up the good work – can’r wait to read more posts.
F*ckin’ tremendous issues here. I’m very glad to look your article. Thanks so much and i’m looking ahead to touch you. Will you kindly drop me a mail?
Heya i’m for the primary time here. I found this board and I find It really useful & it helped me out much. I hope to present something back and aid others such as you helped me.