Panchsheel Organics

VIRTUAL BOOTH, Contact Details

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 2 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

80 All APIs, 80 Listed APIs

Filters

Digital content

Create Content with PharmaCompass, ask us

INTERVIEW #SpeakPharma

[Sponsored by another company]

Expert Take on CEP 2.0: A New Era of Transparency in Pharmaceutical Regulation

At the recent EDQM conference “Certified for Success: Using the CEP Procedure to Elevate Quality and Drive Trust,” regulatory leaders gathered to discuss one of the most significant shifts in European pharmaceutical oversight recently– the transition to CEP 2.0. In the following article, Karina Boszko, Head of Global Regulatory Affairs and Customer Technical Service at Polpharma API, shares her perspective on the new framework and its impact on transforming regulatory strategies for manufacturers worldwide. A strategic shift beyond just compliance. CEP 2.0 is more than a routine update. It represents a fundamental change in how pharmaceutical companies approach transparency, lifecycle management, and international expansion. Rather than focusing solely on documentation, the framework encourages organizations to treat regulatory excellence as a strategic differentiator, shifting the mindset from static compliance to continuous lifecycle oversight. Regulatory alignment thus becomes a living process that evolves with the product, data, and technology. Embedding this approach across teams will foster a culture of iterative improvement, innovation, and stronger organizational resilience. For many manufacturers, however, this will require introducing significant internal changes, from documentation practices to cross-functional collaboration. CEP 2.0 means faster timelines and higher predictability. But only if your team is ready. One of the most anticipated benefits of CEP 2.0 is more predictable review timelines and consistent submissions. However, leveraging these advantages depends heavily on industry readiness. Regulatory teams must adapt to more streamlined, data-driven processes and ensure that digital tools, training, and workflows support accelerated operations. Organizations that modernize will see multiple operational benefits early, including faster project completion, reduced rework, and quicker access to key markets as standardized documentation and cohesive global expectations will make previously complex or "slow” markets more accessible. For companies pursuing international expansion, CEP 2.0 provides a clearer path to global approvals, cross-market consistency, and enhanced competitiveness. Balancing challenges with opportunity. Despite its promise, the transition to CEP 2.0 is not without challenges. Data privacy, operational costs, supply chain complexity, and pressure on low-margin APIs remain key industry concerns that require striking a balance between stringent compliance and long-term sustainability. Still, companies that efficiently integrate regulatory requirements into scalable operations will not only demonstrate the maturity of their quality systems but also build trust externally, strengthening their reputation and differentiating their business in an increasingly competitive market. Looking ahead to a more collaborative future. CEP 2.0 positions the pharmaceutical sector for a future where regulatory excellence drives global competitiveness. Transparency, harmonization, and a lifecycle approach will increasingly define market leaders. The framework’s success, however, requires ongoing dialogue with regulators. Clear, practical guidance from the EDQM, combined with active feedback from manufacturers, is essential. The more open the collaboration, the more effectively CEP 2.0 will support innovation, quality, and patient safety. The question for every organization is how to approach this moment: as a compliance burden, or as a strategic opportunity to elevate quality, accelerate growth, and build long-term trust. Connect with Polpharma API: Your Partner in Pharma AdvancementFor more information on how Polpharma API can be your strategic ally in drug substance development and manufacturing, contact us at api@polpharma.comLet's embark on a journey of innovation and excellence together.

Impressions: 130

VLOG #PharmaReel

[Sponsored by another company]

Smart & Innovative Custom Manufacturing

This PharmaReel highlights PMC Isochem, a smart custom manufacturing partner that offers Generic APIs, cGMP Intermediates, Vitamin E TPGS, and cutting-edge drug delivery materials, supported by trusted CDMO & CRO services and certified by the USFDA and EDQM.

Impressions: 75

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 296 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.

Impressions: 1598

NEWS #PharmaBuzz

[Sponsored by another company]

Panchsheel Organics allotted land for API unit in MP

25 Aug 2024

// CHEMICAL NEWS

Panchsheel Organics to set up fermentation/API unit

27 Nov 2022

// INDIANPHARMAPOST

Contact Panchsheel Organics and get a quotation

Panchsheel Organics is a supplier offers 80 products (APIs, Excipients or Intermediates).

Find a price of Allylestrenol bulk offered by Panchsheel Organics

Find a price of Amiodarone Hydrochloride bulk offered by Panchsheel Organics

Find a price of Atracurium Besylate bulk offered by Panchsheel Organics

Find a price of Azathioprine bulk offered by Panchsheel Organics

Find a price of Azelaic Acid bulk offered by Panchsheel Organics

Find a price of Bacitracin Zinc bulk offered by Panchsheel Organics

Find a price of Baclofen bulk offered by Panchsheel Organics

Find a price of Bisoprolol Fumarate bulk offered by Panchsheel Organics

Find a price of Brimonidine Tartrate bulk offered by Panchsheel Organics

Find a price of Bromelain bulk offered by Panchsheel Organics

Find a price of Bupivacaine bulk offered by Panchsheel Organics

Find a price of Carbamazepine bulk offered by Panchsheel Organics

Find a price of Carbocisteine bulk offered by Panchsheel Organics

Find a price of Desogestrel bulk offered by Panchsheel Organics

Find a price of Dimethyl Fumarate bulk offered by Panchsheel Organics

Find a price of Dipyridamole bulk offered by Panchsheel Organics

Find a price of Dobutamine Hydrochloride bulk offered by Panchsheel Organics

Find a price of Dopamine bulk offered by Panchsheel Organics

Find a price of Doxycycline bulk offered by Panchsheel Organics

Find a price of Dutasteride bulk offered by Panchsheel Organics

Find a price of Epinephrine Bitartrate bulk offered by Panchsheel Organics

Find a price of Eslicarbazepine Acetate bulk offered by Panchsheel Organics

Find a price of Estradiol bulk offered by Panchsheel Organics

Find a price of Ethinyl Estradiol bulk offered by Panchsheel Organics

Find a price of Finasteride bulk offered by Panchsheel Organics

Find a price of Flutamide bulk offered by Panchsheel Organics

Find a price of Fusidic Acid bulk offered by Panchsheel Organics

Find a price of Gadobutrol bulk offered by Panchsheel Organics

Find a price of Gatifloxacin bulk offered by Panchsheel Organics

Find a price of Ginseng Extract bulk offered by Panchsheel Organics

Find a price of Hydroquinone bulk offered by Panchsheel Organics

Find a price of Hydroxyzine Hydrochloride bulk offered by Panchsheel Organics

Find a price of Imipramine Hydrochloride bulk offered by Panchsheel Organics

Find a price of Leflunomide bulk offered by Panchsheel Organics

Find a price of Levothyroxine Sodium bulk offered by Panchsheel Organics

Find a price of Lithium Carbonate bulk offered by Panchsheel Organics

Find a price of Lomefloxacin bulk offered by Panchsheel Organics

Find a price of Mefloquine bulk offered by Panchsheel Organics

Find a price of Melatonin bulk offered by Panchsheel Organics

Find a price of Mercaptopurine bulk offered by Panchsheel Organics

Find a price of Methylcobalamin bulk offered by Panchsheel Organics

Find a price of Mupirocin bulk offered by Panchsheel Organics

Find a price of Mycophenolate Mofetil bulk offered by Panchsheel Organics

Find a price of Nadifloxacin bulk offered by Panchsheel Organics

Find a price of Naphazoline Hydrochloride bulk offered by Panchsheel Organics

Find a price of Neostigmine Methylsulfate bulk offered by Panchsheel Organics

Find a price of Nitazoxanide bulk offered by Panchsheel Organics

Find a price of Nitrofurantoin bulk offered by Panchsheel Organics

Find a price of Nitrofurazone bulk offered by Panchsheel Organics

Find a price of Norepinephrine Bitartrate bulk offered by Panchsheel Organics

Find a price of Norethisterone bulk offered by Panchsheel Organics

Find a price of Oxcarbazepine bulk offered by Panchsheel Organics

Find a price of Palmitoylethanolamide bulk offered by Panchsheel Organics

Find a price of Perindopril Erbumine bulk offered by Panchsheel Organics

Find a price of Phenazon bulk offered by Panchsheel Organics

Find a price of Pirfenidone bulk offered by Panchsheel Organics

Find a price of Pramipexole Dihydrochloride bulk offered by Panchsheel Organics

Find a price of Prednisolone Acetate bulk offered by Panchsheel Organics

Find a price of Promethazine Hydrochloride bulk offered by Panchsheel Organics

Find a price of Propylthiouracil bulk offered by Panchsheel Organics

Find a price of Pyridostigmine bulk offered by Panchsheel Organics

Find a price of Rifapentine bulk offered by Panchsheel Organics

Find a price of Rocuronium Bromide bulk offered by Panchsheel Organics

Find a price of Ropivacaine Hydrochloride bulk offered by Panchsheel Organics

Find a price of Rupatadine Fumarate bulk offered by Panchsheel Organics

Find a price of Rutin bulk offered by Panchsheel Organics

Find a price of Serratiopeptidase bulk offered by Panchsheel Organics

Find a price of Sodium Cromoglicate bulk offered by Panchsheel Organics

Find a price of Tacrolimus bulk offered by Panchsheel Organics

Find a price of Thalidomide bulk offered by Panchsheel Organics

Find a price of Timolol Maleate bulk offered by Panchsheel Organics

Find a price of Torsemide bulk offered by Panchsheel Organics

Find a price of Tretinoin bulk offered by Panchsheel Organics

Find a price of Tropicamide bulk offered by Panchsheel Organics

Find a price of Vecuronium Bromide bulk offered by Panchsheel Organics

Find a price of Verapamil bulk offered by Panchsheel Organics

Find a price of Vitamin E bulk offered by Panchsheel Organics

Find a price of Vitamin K1 bulk offered by Panchsheel Organics

Find a price of Vitamin K2 bulk offered by Panchsheel Organics

Find a price of Xylometazoline bulk offered by Panchsheel Organics

Privacy policy
Terms and conditions
Disclaimers
Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.