Indian multinational pharmaceutical company headquartered in Mumbai, focused on medication for respiratory disease, cardiovascular disease, arthritis, diabetes, and depression; operates 47 manufacturing locations globally and is the third-largest drug producer in India.
Clinical Trials
38
13 active
Approvals
33
Total approvals
Agencies
2
Regulatory bodies
Founded
1935
Active, not recruiting
1
2.6%
Completed
21
55.3%
Not yet recruiting
12
31.6%
Recruiting
4
10.5%
- India's three Production Linked Incentive schemes for pharmaceuticals, bulk drugs and medical devices have drawn ₹46,744 crore in actual pharma investment against a ₹17,275 crore target as of June 2026. - The bulk drugs scheme has commissioned 39 projects covering 28 APIs, enabling domestic production of Penicillin-G, Clavulanic Acid and Rifampicin that were previously largely imported. - The medical devices scheme has started production of 57 unique devices including MRI machines, CT scanners, Cath Labs and linear accelerators, with a 5 per cent incentive on incremental sales for five years. - Global manufacturers including GE Healthcare, Siemens, Philips, Varex, Nipro and Omron have established or expanded Indian manufacturing operations under the schemes.
- India's CGPDTM published Draft Guidelines for examination of pharmaceutical patent applications on September 4, 2026, inviting public comments before finalisation. - The draft rebuilds the examiner's framework around roughly two dozen judicial decisions, including the 2013 Novartis ruling and Delhi High Court judgments from 2024–2026. - Section 3(d) efficacy analysis is reinforced as a data-driven inquiry, with bioavailability clarified as a pharmacokinetic parameter rather than a direct measure of therapeutic efficacy. - New structured tests for novelty ("Seven Stambha") and inventive step, plus dedicated treatment of Markush and product-by-process claims, signal stricter prosecution standards.
- Cipla has entered an exclusive licensing and supply agreement with Sino Biopharmaceutical's subsidiary Chia Tai Tianqing (CTTQ) for the HER2 bispecific antibody-drug conjugate TQB2102 (Rolditamig Deuderuxtecan). - The deal grants Cipla exclusive development and commercialization rights across India, South Africa, and five other emerging markets, while CTTQ retains manufacturing and supply responsibilities. - TQB2102 has shown encouraging clinical potential in HER2-low advanced breast cancer and has secured three Breakthrough Therapy Designations from China's National Medical Products Administration. - The agreement strengthens Cipla's oncology pipeline with a late-stage, differentiated ADC asset without requiring early-stage drug discovery investment.
- PH Kurien, India's Controller General of Patents, issued the country's first compulsory licence on 9 March 2012, allowing Natco Pharma to produce Bayer's cancer drug Nexavar. - The ruling slashed the monthly treatment cost from over ₹2.8 lakh to ₹8,800, a reduction of about 97%, dramatically improving access for kidney and liver cancer patients. - The Patent Office found Bayer had failed to "work" its patent in India and was reaching only about 2% of the estimated 88,000 patients who needed the drug. - No further compulsory licences have been granted since, which health activists attribute to sustained pressure from multinational pharmaceutical companies.
- Cipla Limited received U.S. FDA approval for its ANDA for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all three strengths: 100/50 mcg, 250/50 mcg, and 500/50 mcg. - The approval represents Cipla's first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network, specifically its New York facility. - The U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million, according to IQVIA data. - The generic is a therapeutically equivalent version of Advair Diskus, indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
- The USFDA classified the July 2026 cGMP inspection of InvaGen Pharmaceuticals' Unit 3 facility in Central Islip, New York, as Voluntary Action Indicated (VAI). - The VAI classification confirms the facility remains largely compliant, avoiding disruptive regulatory actions such as Warning Letters or Import Alerts. - The single Form 483 observation issued during the July 13–17, 2026 inspection was successfully addressed, supporting uninterrupted generic drug supply to the U.S. market. - The outcome removes regulatory overhang for Cipla's U.S. business and keeps the pipeline of pending ANDA approvals from the facility intact.
- The global biosimilar market expanded fifteen-fold from US$2.2 billion in 2016 to roughly US$32.7 billion in 2024, with Korea and India serving as its manufacturing engine room. - Despite record revenues at Celltrion, Samsung Bioepis, and Biocon, APAC manufacturers face a structural "value trap" where US pharmacy benefit managers capture the economic upside through private-label biosimilars. - The FDA is dismantling interchangeability requirements, proposing to eliminate comparative clinical efficacy studies, which simultaneously lowers development costs and erodes product differentiation. - Some 118 biologics worth US$232 billion in US sales lose exclusivity through 2034, yet only 10% have a biosimilar in active development, revealing a "biosimilar void" driven by poor return economics.
- Orchid Pharma signed an exclusive licensing and supply agreement with Pharmasyntez JSC for Exblifep in Russia, with a potential revenue opportunity of $178 million over 10 years. - The company is in advanced discussions to out-license enmetazobactam in the United States, with a deal expected in the near term following FDA approval in February 2024. - Exblifep (cefepime/enmetazobactam) targets serious Gram-negative infections including cUTI and HAP/VAP, with lifetime global sales potential estimated at $1 billion to $2 billion. - Orchid is pursuing multi-region licensing deals across Japan, Latin America, and Southeast Asia, with at least half of these partnerships expected to be signed in the coming quarters.
- MedTherapy, funded by Tata Sons, operates as a contract development and manufacturing organization (CDMO) with facilities in Boston and New Delhi to reduce CAR-T therapy production costs and timelines. - The company has developed manufacturing platforms that can produce CAR-T therapies in one day compared to several weeks for industry standard, targeting both blood cancers and solid tumors. - MedTherapy collaborates with 22 global academic institutes including Harvard University and has partnerships with Cipla for cell and gene therapy development in India. - The company's blood cancer CAR-T therapy program has completed clinical studies in the US and is preparing for clinical trials in India, demonstrating promising response rates and safety profiles.
- Pfizer reached settlements with Dexcel Pharma, Hikma Pharmaceuticals, and Cipla to extend tafamidis patent protection through June 1, 2031, preventing generic competition until early next decade. - The agreements ensure U.S. revenues for Vyndamax, which generated nearly $6.4 billion worldwide last year, will remain relatively stable from 2028 through mid-2031 instead of facing significant decline. - Tafamidis is the market-leading treatment for transthyretin-mediated amyloidosis cardiomyopathy, a rare heart disease that has proven to be a much larger commercial opportunity than previously anticipated. - The patent extension impacts the competitive landscape for other companies developing treatments for the same condition, including BridgeBio Pharma's Attruby and Alnylam Pharmaceuticals' Amvuttra.
